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510(k) Data Aggregation

    K Number
    K050817
    Device Name
    T-TEK
    Manufacturer
    R2 DIAGNOSTICS, INC.
    Date Cleared
    2005-12-12

    (256 days)

    Product Code
    GJA
    Regulation Number
    864.7875
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated plasma. The thrombin time test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals.
    Device Description
    The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated human plasma. The thrombin time test is a one-stage quantitative clotting test performed on citrated plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals. The test may be performed manually, or using semi-automated and automated coagulation analyzers.
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    K Number
    K970645
    Device Name
    BC THROMBIN REAGENT
    Manufacturer
    BEHRING DIAGNOSTICS, INC.
    Date Cleared
    1997-05-19

    (88 days)

    Product Code
    GJA
    Regulation Number
    864.7875
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BC Thrombin Reagent is intended for the determination of the thrombin time in human plasma. The determination of thrombin time is important in: - The monitoring of heparin therapy. - The monitoring of fibrinolysis therapy. - The screening of disorders of fibrin formation. - The differentiating between a heparin-induced prolongation of the thrombin time and fibrin formation disorders.
    Device Description
    The BC Thrombin Reagent consists of lyophilized bovine thrombin and bovine albumin, and buffer solution (HEPES).
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