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510(k) Data Aggregation

    K Number
    K973014
    Device Name
    QUANTA LITE B2GPI IGM
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1997-10-20

    (68 days)

    Product Code
    MSV
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    K982433
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    semiquantitative enzyme linked immunoassay for detecting IgM at class autoantibody to for glycoprotein I (Ag GPT) for use as an aid certain autoimmune disease thrombotic diagnosis of " the in in the "diagnobis" of "cercain" addemmic lupus erythematosus (SLE) or other lupus-like disorders.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry. I cannot provide information on the acceptance criteria and study as the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain details about specific acceptance criteria or a study proving the device meets them. It primarily states that the device is substantially equivalent to a predicate device and can be marketed.

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