BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Gonococcal Antibody Tests

    PMA: P770001 · Decision Jul 18, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Gonococcal Antibody Tests
    Trade Name
    FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)
    PMA Number
    P770001
    Device Class
    FDA Class 3
    Product Code
    LGB
    Generic Name
    GONOCOCCAL ANTIBODY TESTS
    Regulation Number
    866.3290
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 18, 1979
    Date Received
    May 20, 1977
    Expedited Review
    N

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGB Gonococcal Antibody Tests