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510(k) Data Aggregation

    K Number
    K072304
    Device Name
    FIBRINOGEN CALIBRATOR KIT
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2007-09-19

    (33 days)

    Product Code
    GFX
    Regulation Number
    864.7340
    Why did this record match?
    Product Code :

    GFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibren™ U.
    Device Description
    The Fibrinogen Calibrators are lyophilized calibrators prepared using pooled human plasma from selected, healthy donors that has been diluted with buffer solution or supplemented with purified fibrinogen and stabilized.
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    K Number
    K994341
    Device Name
    FIBRINOGEN CALIBRATOR KIT
    Manufacturer
    DADE BEHRING, INC.
    Date Cleared
    2000-03-03

    (71 days)

    Product Code
    GFX
    Regulation Number
    864.7340
    Why did this record match?
    Product Code :

    GFX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fibrinogen Calibrators 1 to 6 are used to prepare reference curves for the assay of fibrinogen by the method of Clauss using Dade Behring Multifibrin U.
    Device Description
    The Fibrinogen Calibrators are lyophilized calibrators prepared from pooled human plasma from selected, healthy donors, diluted with buffered solution or supplemented with purified fibrinogen and stabilized.
    Ask a Question

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