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510(k) Data Aggregation

    K Number
    K980312
    Device Name
    NOVA LITE ENDOMYSIAL
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    1998-04-02

    (65 days)

    Product Code
    DBL
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NOVA LITE ENDOMYSIAL

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

    An indirect immunofluorescent antibody test for the qualitative and semi-quantitative detection of IgA class endomysial autoantibodies (EMA) in human serum as an aid in the diagnosis of celiac disease and dermatitis herpetiformis.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but without further textual input, I cannot furnish information about acceptance criteria or supporting studies. The documents you provided appear to be an FDA 510(k) clearance letter and an "Indications For Use" statement for the "NOVA Lite™ Endomysial Antibody Test Kit," but they do not contain details regarding specific performance criteria or the studies conducted to demonstrate those criteria.

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