LogoFDA 510(k) Search
Search Filters

Search Results

Found 7 results

510(k) Data Aggregation

    K Number
    K012907
    Device Name
    LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL
    Manufacturer
    CLINICAL CONTROLS
    Date Cleared
    2001-09-28

    (30 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Why did this record match?
    Applicant Name (Manufacturer) :

    CLINICAL CONTROLS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Clinical Controls LiquiSPx™ Liquid Saliva/Urine Drugs of Abuse Control is a ready-to-use, assayed chemistry control materials for monitoring the accuracy and precision of available analytical procedures. Drug analysis consisting of measuring amphetamine, methamphetamine, phencyclidine, cocaine, tetrahydrocanabinol and morphine is used to assist in the detection and management of drug abuse in at risk patient populations.
    Device Description
    Liquid Saliva/Urine Drugs of Abuse Control
    Ask a Question

    Ask a specific question about this device

    K Number
    K012855
    Device Name
    LIQUISPX LIQUID LIPID CONTROL
    Manufacturer
    CLINICAL CONTROLS DIVISION
    Date Cleared
    2001-08-30

    (6 days)

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

    CLINICAL CONTROLS DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Clinical Controls LiquiSPx Liquid Lipid control is a ready-to-use, assayed chemistry control material for monitoring the accuracy and precision of lipid chemistry control material for monitoring the automated analytical procedures. Lipid analysis consists of measuring total cholesterol, triglycerides, HDL and LDL cholesterol. It is used to assist in the diagnosis and management of LDL cholesterol. This dood to assist in tisk patient populations.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    K Number
    K010030
    Device Name
    LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR
    Manufacturer
    SYNERGENT BIOCHEM INC.-CLINICAL CONTROLS DIV.
    Date Cleared
    2001-02-14

    (42 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    -CLINICAL CONTROLS DIV

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

    Ask a specific question about this device

    K Number
    K964278
    Device Name
    WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6
    Manufacturer
    CLINICAL CONTROLS, INC.
    Date Cleared
    1996-11-22

    (25 days)

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

    CLINICAL CONTROLS, INC

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

    Ask a specific question about this device

    K Number
    K962432
    Device Name
    LIQUISPEX URINE (MICRO)ALBUMIN CONTROL
    Manufacturer
    CLINICAL CONTROLS, INC.
    Date Cleared
    1996-07-05

    (11 days)

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

    CLINICAL CONTROLS, INC

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

    Ask a specific question about this device

    K Number
    K955690
    Device Name
    AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3
    Manufacturer
    CLINICAL CONTROLS, INC.
    Date Cleared
    1996-04-24

    (132 days)

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

    CLINICAL CONTROLS, INC

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

    Ask a specific question about this device

    K Number
    K955691
    Device Name
    SERUM VOLATILES CONTROL LEVEL 1 & 2
    Manufacturer
    CLINICAL CONTROLS, INC.
    Date Cleared
    1996-04-24

    (132 days)

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

    CLINICAL CONTROLS, INC

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

    Ask a specific question about this device

    Page 1 of 1