BEUDAMED
    FDA PMA FDA Class 1 Approved 🇺🇸 United States

    Test Reagents, Neisseria Gonorrhoeae Biochemical

    PMA: P770010 · Supplement: S001 · Decision Jun 10, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Test Reagents, Neisseria Gonorrhoeae Biochemical
    Trade Name
    GONODECTEN
    PMA Number
    P770010
    Supplement Number
    S001
    Device Class
    FDA Class 1
    Product Code
    LTS
    Generic Name
    TEST REAGENTS, NEISSERIA GONORRHOEAE BIOCHEMICAL
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 10, 1980
    Date Received
    June 10, 1980
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LTS Test Reagents, Neisseria Gonorrhoeae Biochemical