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510(k) Data Aggregation

    K Number
    K972257
    Device Name
    N-ASSAY TIA ANTITHROMBIN III TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-10-20

    (125 days)

    Product Code
    DDQ, JBQ
    Regulation Number
    864.7060
    Why did this record match?
    Product Code :

    DDQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the N-Assay TIA Antithrombin III Test Kit is for the quantification of human antithrombin III in human plasma. AT- III levels less than 60% of normal are associated with increased risk of thromboembolism. The assay of plasma AT-TII is also helpful in monitoring heparin therapy.
    Device Description
    Not Found
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