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

    THROMBOPLASTIN.C

    K Number: K874592 · Decision Feb 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    126
    Applicant Total
    505
    Review Days
    87

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    Basic Information

    Device Name
    THROMBOPLASTIN.C
    K Number
    K874592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7750
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Baxter Healthcare Corp
    Date Received
    November 9, 1987
    Decision Date
    February 4, 1988
    Product Code
    GJS
    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
    GJS Test, Time, Prothrombin

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