BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BIOMERIEUX HEMOLAB FIBRINOMAT

    K Number: K925494 · Decision May 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    49
    Review Days
    197

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    Basic Information

    Device Name
    BIOMERIEUX HEMOLAB FIBRINOMAT
    K Number
    K925494
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomerieux Vitek, Inc.
    Date Received
    November 2, 1992
    Decision Date
    May 18, 1993
    Product Code
    GIS
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GIS Test, Fibrinogen

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    Other Clearances by Biomerieux Vitek, Inc.

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    K955627 VIDAS CHLAMYDIA BLOCKING ASSAY
    K962549 VIDAS CREATINE KINASE MB ASSAY 30-421
    K962609 GRAM NEGATIVE IDENTIFICATION PLUS CARD
    K952095 VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
    K955647 VIDAS ESTRADIOL II (E2II) ASSAY
    K943812 VIDAS LYME SCREEN II
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