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

    KINETIC FIBRINOGEN ASSAY

    K Number: K881150 · Decision Mar 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    37
    Review Days
    11

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    Basic Information

    Device Name
    KINETIC FIBRINOGEN ASSAY
    K Number
    K881150
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Bio/Data Corp.
    Date Received
    March 17, 1988
    Decision Date
    March 28, 1988
    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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