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510(k) Data Aggregation

    K Number
    K962407
    Device Name
    N/T PROTEIN CONTROL PY
    Manufacturer
    BEHRING DIAGNOSTICS, INC.
    Date Cleared
    1996-07-29

    (38 days)

    Product Code
    GIL, DBA, DEM, GIT, JJX
    Regulation Number
    864.7340
    Why did this record match?
    Product Code :

    GIL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    N/T Protein Control PY is used for control of accuracy and precision in the quantitative immunochemical determination of alpha -- Antitrypsin, fibrinogen, antithrombin III, prothrombin, plasminogen, fibronectin*, C+ Inhibitor with the Behring Nephelometer Systems and with the TurbiTimeSystem. *not available in the U.S.
    Device Description
    The N/T Protein Control PY is a lyophilized pool of citrate plasma consisting of one level containing the following proteins: fibrinogen antithrombin III prothrombin plasminogen alpha 1 - Antitrypsin C1 Inhibitor
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