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510(k) Data Aggregation

    K Number
    K971653
    Device Name
    GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM
    Manufacturer
    CLINICAL DIAGNOSTICS, INC.
    Date Cleared
    1998-01-02

    (241 days)

    Product Code
    CGA
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM is intended for the quantitative measurement of glucose in capillary whole blood.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for the Glucochek Pocketlab II Blood Glucose System, indicating that the device has been determined to be substantially equivalent to previously marketed devices.

    This type of document typically does not include the detailed study results, acceptance criteria, or performance metrics. It primarily confirms the FDA's decision regarding market clearance.

    Therefore, I cannot provide the requested information based on the given text.

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