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

    THROMBOQUIK THROMBIN REAGENT PROD. #3551

    K Number: K800926 · Decision May 8, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    19
    Applicant Total
    39
    Review Days
    17

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    Basic Information

    Device Name
    THROMBOQUIK THROMBIN REAGENT PROD. #3551
    K Number
    K800926
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7875
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    General Diagnostics
    Date Received
    April 21, 1980
    Decision Date
    May 8, 1980
    Product Code
    GJA
    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
    GJA Test, Thrombin Time

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