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

    ASSAY KIT, THROMBO-SCREEN

    K Number: K781880 · Decision Dec 4, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    12
    Applicant Total
    29
    Review Days
    28

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    Basic Information

    Device Name
    ASSAY KIT, THROMBO-SCREEN
    K Number
    K781880
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7340
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Pacific Hemostasis
    Date Received
    November 6, 1978
    Decision Date
    December 4, 1978
    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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