BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Kit, Test,Alpha-Fetoprotein For Testicular Cancer

    PMA: P820060 · Supplement: S019 · Decision Feb 2, 2004
    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
    PMA Number
    P820060
    Supplement Number
    S019
    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
    February 2, 2004
    Date Received
    August 14, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN PROTOCOL FOR THE AUTOMATED DILUTION PROTOCOL IN ABBOTT AXSYM SOFTWARE VERSION 3.60 AND VERSION 4.01.

    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