BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Kit, Test,Alpha-Fetoprotein For Testicular Cancer

    PMA: P820060 · Supplement: S009 · Decision Dec 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Kit, Test,Alpha-Fetoprotein For Testicular Cancer
    Trade Name
    ABBOTT AXSYM AFP (LIST 7A48)
    PMA Number
    P820060
    Supplement Number
    S009
    Device Class
    FDA Class 2
    Product Code
    LOJ
    Generic Name
    KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 26, 1995
    Date Received
    November 22, 1995
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION OF THE POTENCY TEST FOR THE ANTI-AFP: ALKALINE PHOSPHATASE CONJUGATE

    Classifications

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

    Product Code Device Name
    LOJ Kit, Test,Alpha-Fetoprotein For Testicular Cancer