BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    System, Test, Carcinoembryonic Antigen

    PMA: P840019 · Supplement: S006 · Decision Apr 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    System, Test, Carcinoembryonic Antigen
    Trade Name
    TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY
    PMA Number
    P840019
    Supplement Number
    S006
    Device Class
    FDA Class 2
    Product Code
    DHX
    Generic Name
    SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 30, 1987
    Date Received
    February 9, 1987
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    DHX System, Test, Carcinoembryonic Antigen