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510(k) Data Aggregation

    K Number
    K250067
    Device Name
    Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro
    Date Cleared
    2025-02-20

    (41 days)

    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou De**cheng **Biotechnology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations. Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a postive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method. Dochek® Multi-Drug Urine Test Cup Pro is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations. Dochek® Multi-Drug Urine Test Cup Pro offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    Dochek® Multi-Drug Urine Test Cup Pro and Dochek® Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine at or above the cut-off levels as indicated. The products are single use in vitro diagnostic medical devices. This device is a cup format, with the test strips integrated into the plastic cup provided, and the urine sample is collected directly into the cup containing the strips. Each cup device is sealed in an aluminum foil pouch with two sachets of desiccant. The device is in a ready-to-use format and no longer requires assembly before use.
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    K Number
    K242428
    Device Name
    Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus
    Date Cleared
    2025-02-06

    (175 days)

    Product Code
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou De**cheng **Biotechnology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dochek® Fentanyl Urine Test Strip Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentany] Urine Test Card Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Cup Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Strip is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Card is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive. Dochek® Fentanyl Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
    Device Description
    Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentany1 Urine Test Card, Dochek® Fentany] Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus are immunochromatographic assays that use a lateral flow system for the qualitative detection of fentanyl in human urine. Test Strip, Test Card and Test Cup use identical test strips made with same chemical formulation and manufacturing procedures.
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    K Number
    K241120
    Device Name
    Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S)
    Date Cleared
    2024-06-24

    (62 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Qiao**cheng **Li (Dongguan) Medical Instruments Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intense pulsed light therapy apparatus is an over-the-counter device intended for removal of unwanted body and/or facial hair.
    Device Description
    Intense pulsed light therapy apparatus is an over-the-counter, home-use, light based device for unwanted hair reduction by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device includes 12 model: FDA01, FDA02, FDA03, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S), the model name with an "S" indicates that the model has a cooling function. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission, and the device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses.
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    K Number
    K240643
    Device Name
    MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream
    Date Cleared
    2024-06-21

    (106 days)

    Product Code
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou De**cheng **Biotechnology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MissLan® Early Detection Pregnancy Test Strip is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This device is intended for home-use only. MissLan® Early Detection Pregnancy Test Cassette is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This device is intended for home-use only. MissLan® Early Detection Pregnancy Test Midstream is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, (i.e. as early as five (5) days before the day of the expected period). It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over-the-counter use. Important note regarding positive results: Because this test detects low levels of hCG, it is possible that this test may give positive results even if you are not pregnant. All results should be confirmed by your healthcare provider, especially when making decisions about future medical care. This device is intended for home-use only.
    Device Description
    MissLan® Early Detection Pregnancy Test will be sold in Strip. Cassette and Midstream format. The Strip format is a single test strip. The Cassette format consists of a single test strip assembled in a plastic housing. The Midstream format consists of a single test strip assembled in a plastic housing with an absorbent tip, and is designed to be tested in dip or midstream mode. MissLan® Early Detection Pregnancy Test Strip. MissLan® Early Detection Pregnancy Test Cassette and MissLan® Early Detection Pregnancy Test Midstream each contains a pouch with the device and instructions, and in addition, cassette format is packaged with pipette dropper and urine collection cup. The devices utilize a combination of antibodies to detect hCG in urine as well as to serve as a run control. Each device contains mouse monoclonal anti-ß-hCG antibody colloidal gold conjugate pre-dried on the sample pad. Mouse monoclonal anti-a-hCG antibody (on the Test Line) and goat anti mouse IgG polyclonal antibody (on the Control Line) are coated and immobilized on a nitrocellulose membrane. The result is displayed to the user in the test window as two lines for a 'Pregnant' positive result and one line for a 'Not Pregnant' negative result.
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    K Number
    K240698
    Device Name
    Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard
    Date Cleared
    2024-05-10

    (57 days)

    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou De**cheng **Biotechnology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dochek® Multi-Drug Urine Test Dipcard Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations: Amphetamine (AMP) 1000 or 500 ng/mL Secobarbital (BAR) 300 ng/mL Buprenorphine (BUP) 10 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 300 or 150 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Methamphetamine (MET) 1000 or 500 ng/mL Morphine (MOP/OPI) 300 or 2000 ng/mL Methadone (MTD) 300 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL Propoxyphene (PPX) 300 ng/mL Nortriptyline (TCA) 1000 ng/mL Cannabinoids (THC) 50 ng/mL 6-Monoacetylmorphine (6-MAM) 10 ng/mL Dochek® Multi-Drug Urine Test Dipcard Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for prescription use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS is the recommended confirmatory method. Dochek® Multi-Drug Urine Test Dipcard is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations: Amphetamine (AMP) 1000 or 500 ng/mL Secobarbital (BAR) 300 ng/mL Buprenorphine (BUP) 10 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 300 or 150 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Methamphetamine (MET) 1000 or 500 ng/mL Morphine (MOP/OPI) 300 or 2000 ng/mL Methadone (MTD) 300 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL Propoxyphene (PPX) 300 ng/mL Nortriptyline (TCA) 1000 ng/mL Cannabinoids (THC) 50 ng/mL 6-Monoacetylmorphine (6-MAM) 10 ng/mL Dochek® Multi-Drug Urine Test Dipcard offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    Dochek® Multi-Drug Urine Test Dipcard Rx and Dochek® Multi-Drug Urine Test Dipcard are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine at or above the cut-off levels as indicated. The products are singleuse in vitro diagnostic devices. This device is a dipcard format in which the test strips are integrated into the plastic dipcard. After removing the cap of the dipcard, the absorbent end of the test strips is exposed and can be in direct contact with the urine sample. The device is in a ready-to-use format and no longer requires assembly before use.
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    K Number
    K233016
    Device Name
    Dental Glass Ceramics
    Date Cleared
    2023-12-21

    (90 days)

    Product Code
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Yuru**cheng **Dental Materials Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Once finalized into a suitable design, the Dental Glass Ceramics are indicated for use as inlays, onlays, veneer, partial crowns and crowns.
    Device Description
    Dental Glass Ceramics is composed of SiO2, Li2O, K2O,P2O5,Al2O3 and other oxides. The block is intended to be processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method. The block is a single-use device and provided non-sterile. The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.
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    K Number
    K232659
    Device Name
    Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
    Date Cleared
    2023-12-13

    (104 days)

    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou De**cheng **Biotechnology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dochek® Multi-Drug Urine Test Cup Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table. Dochek® Multi-Drug Urine Test Cup Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device . It is intended for prescription use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result,particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method. Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the cutoff concentrations of following table. Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device . It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only. The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result,particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
    Device Description
    Dochek® Multi-Drug Urine Test Cup Rx and Dochek® Multi-Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The device is a cup format. The test strips are integrated into the cup provided and the urine sample is collected directly into the cup containing the strips. Each cup device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
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    K Number
    K230776
    Device Name
    Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro)
    Date Cleared
    2023-06-09

    (80 days)

    Product Code
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Lutejia**cheng **Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Momcozy Wearable Electric Breast Pump (Model: S9 Pro, S12 Pro) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
    Device Description
    Not Found
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    K Number
    K223693
    Device Name
    Electric breast pump (model: M5)
    Date Cleared
    2023-03-09

    (90 days)

    Product Code
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Lutejia**cheng **Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Electric breast pump (model: M5) is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
    Device Description
    Electric breast pump (model: M5)
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    K Number
    K230038
    Device Name
    MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
    Date Cleared
    2023-02-28

    (53 days)

    Product Code
    Regulation Number
    862.1155
    Why did this record match?
    Applicant Name (Manufacturer) :

    Guangzhou De**cheng **Biotechnology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MissLan® Pregnancy Rapid Test (Strip) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use. MissLan® Pregnancy Rapid Test (Midstream) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.
    Device Description
    MissLan® Pregnancy Rapid Test will be sold in Midstream and Strip format. The Midstream format consists of a single test strip assembled in a plastic housing, with an absorbent tip, and is designed to be tested in dip or midstream mode. The Strip format is a single test strip. The Midstream format contains one Test Midstream sealed in a desiccated aluminum pouch and Instructions for Use. The Strip format contains one Test strip sealed in a desiccated aluminum pouch, Urine Collection Cup and Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.
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