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510(k) Data Aggregation

    K Number
    K993850
    Device Name
    URINALYSIS REAGENT STRIPS (10 PARAMETERS)
    Manufacturer
    INTERNATIONAL NEWTECH DEVELOPMENT, INC.
    Date Cleared
    2000-01-03

    (52 days)

    Product Code
    JMT, CDM, CEN, CIN, JIL, JIN, JIO, JIR, JJB, JMA, JMZ, JRE, LJX
    Regulation Number
    862.1510
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL NEWTECH DEVELOPMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Urinalysis Reagent Strips provide tests for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leucocytes in urine.
    Device Description
    Not Found
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    K Number
    K974059
    Device Name
    ONE STEP MIDSTREAM HCG PREGNANCY TEST
    Manufacturer
    INTERNATIONAL NEWTECH DEVELOPMENT, INC.
    Date Cleared
    1998-04-09

    (164 days)

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

    INTERNATIONAL NEWTECH DEVELOPMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    One Step Midstream Style HCG Pregnancy Test is a test kit for the determination of One Brep Midsh Cam Biye 1100 room and and in urine specimens and in turn for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative results for home use.
    Device Description
    One Step Midstream Style HCG Pregnancy Test is a test kit for the determination of One Brep Midsh Cam Biye 1100 room and and in urine specimens and in turn for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative results for home use.
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    K Number
    K974060
    Device Name
    MINISTRIP/ SERUM AND URINE COMBO HCG TEST
    Manufacturer
    INTERNATIONAL NEWTECH DEVELOPMENT, INC.
    Date Cleared
    1998-04-09

    (164 days)

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

    INTERNATIONAL NEWTECH DEVELOPMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MiniStrip/ Serum and Urine Combo HCG test is a qualitative, two sites sandwich immunoassay test kit for rapid determination of hCG concentration in both serum and urine for early detection of pregnancy. This test kit is used to obtain a visual and qualitative result and is for clinical lab used only.
    Device Description
    Not Found
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    K Number
    K974009
    Device Name
    PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
    Manufacturer
    INTERNATIONAL NEWTECH DEVELOPMENT, INC.
    Date Cleared
    1998-03-13

    (143 days)

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

    INTERNATIONAL NEWTECH DEVELOPMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PS - UNIT CASSETTE/ Serum and Urine Combo HCG test is a qualitative, two ne and the blogs as accesses test kit for rapid determination of hCG concect to PS - UNT CASSETTE/ Serum and Urine Combo HCG test is a qualification sites sandwich images ay test kit for rapid determination of hCG conceration of the same begine for esty sites sandwich immunoassy test kit for rapid determination of new to in both serum and wine for early detection of pregnancy. This test kit is used to in both serum and secur in both serum and urine for early detection of progently of the your by obtain a visual and qualitative result and is for clinical lab used.
    Device Description
    Not Found
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    K Number
    K970176
    Device Name
    HCG CONTROLS
    Manufacturer
    INTERNATIONAL NEWTECH DEVELOPMENT, INC.
    Date Cleared
    1997-02-06

    (20 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL NEWTECH DEVELOPMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K963132
    Device Name
    MINI STRIP/SERUM HCG
    Manufacturer
    INTERNATIONAL NEWTECH DEVELOPMENT, INC.
    Date Cleared
    1996-11-18

    (98 days)

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

    INTERNATIONAL NEWTECH DEVELOPMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963133
    Device Name
    PS-UNIT CASSETTE/SERUM HCG
    Manufacturer
    INTERNATIONAL NEWTECH DEVELOPMENT, INC.
    Date Cleared
    1996-11-18

    (98 days)

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

    INTERNATIONAL NEWTECH DEVELOPMENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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