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    K Number
    K070183
    Device Name
    KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
    Manufacturer
    KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
    Date Cleared
    2007-07-13

    (175 days)

    Product Code
    OCN
    Regulation Number
    866.5660
    Why did this record match?
    Product Code :

    OCN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KRONUS Insulin Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to insulin in human serum. The KRONUS Insulin Autoantibody RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.
    Device Description
    Not Found
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