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510(k) Data Aggregation

    K Number
    K983692
    Device Name
    ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    1999-02-05

    (107 days)

    Product Code
    MID
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    K983692
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    In-vitro measurement of IgG anticardiolipin antibodies in human serum, as an aid in the diagnosis of anticardiolipin syndrome.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding the clearance of a medical device, the "Anticardiolipin IgG Screen EIA Kit." It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily addresses the device's substantial equivalence to a predicate device and its regulatory classification.

    Therefore, I cannot extract the requested information as it is not present in the provided document.

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