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510(k) Data Aggregation

    K Number
    K991741
    Device Name
    BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
    Manufacturer
    BIOCHECK, INC.
    Date Cleared
    1999-07-22

    (62 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BioCheck hCG ELISA is intended for the quantitative determination of human chorionic gonadotropin (hCG) in serum. This assay is to be used for the early detection of pregnancy in a clinical laboratory setting.

    Device Description

    BioCheck human Chorionic Gonadotropin Enzyme Immunoassay Test Kit (hCG-ELISA)

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the BioCheck human Chorionic Gonadotropin Enzyme Immunoassay Test Kit (hCG-ELISA). It does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot provide the requested table and study information based on the given input. The letter primarily confirms that the device has been reviewed and found substantially equivalent to a legally marketed predicate device, allowing it to proceed to market under general controls and applicable special controls.

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