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510(k) Data Aggregation

    K Number
    K112834
    Device Name
    MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
    Date Cleared
    2012-03-28

    (182 days)

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

    VERICHEM LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Carbon Dioxide Standard Kit is an in vitro diagnostic product intended for<br>calibration or calibration verification of carbon dioxide test systems. The Urine Chemistry Standard Kit is an in vitro diagnostic product intended for<br>calibration or calibration verification of clinical chemistry test systems. The Urine Uric Acid Standard Kit is an in vitro diagnostic product intended for<br>calibration or calibration verification of clinical chemistry test systems. The Electrolyte Standard Kit is an in vitro diagnostic product intended for calibration or<br>calibration verification of serum electrolyte test systems. The Cholesterol Standard Kit is an in vitro diagnostic product intended for calibration<br>or calibration verification of clinical chemistry test systems. The Uric Acid Standard Kit is an in vitro diagnostic product intended for calibration or<br>calibration verification of clinical chemistry test systems. The ISE Standard Kit is an in vitro diagnostic product intended for calibration or<br>calibration verification of clinical chemistry test systems. The ISE Standard (S4) is an in vitro diagnostic product intended for calibration or<br>calibration verification of clinical chemistry test systems. The Multi-Chemistry Standard Kit is an in vitro diagnostic product intended for<br>calibration or calibration verification of clinical chemistry test systems :
    Device Description
    All calibrator materials included in this submission are aqueous, primary standards containing known amounts of each component for in vitro diagnostic use. Standardization is achieved by gravimetric procedure. Verification is performed using available NIST Standard Reference materials.
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    K Number
    K974290
    Device Name
    MICROPROTEIN STANDARD KIT
    Date Cleared
    1997-12-19

    (35 days)

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

    VERICHEM LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Microprotein Standard Kit is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
    Device Description
    MICROPROTEIN STANDARD KIT
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    K Number
    K973345
    Device Name
    MATRIX PLUS MULTI-CALIBRATOR KIT
    Date Cleared
    1997-10-29

    (54 days)

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

    VERICHEM LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MATRIX PLUS Multi-calibrator Kit is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
    Device Description
    MATRIX PLUS MULTI-CALIBRATOR KIT
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    K Number
    K972333
    Device Name
    AMMONIA/IRON STANDARD KIT
    Date Cleared
    1997-07-23

    (30 days)

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

    VERICHEM LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ammonia/Iron Standard Kit is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.
    Device Description
    Not Found
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