BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    System, Test, Carcinoembryonic Antigen

    PMA: P830066 · Supplement: S012 · Decision Jul 12, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    System, Test, Carcinoembryonic Antigen
    Trade Name
    ABBOTT CEA-RIA MONOCLONAL
    PMA Number
    P830066
    Supplement Number
    S012
    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
    July 12, 1995
    Date Received
    June 14, 1995
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATION OF THE PACKAGE LABELING TO DECREASE THE "HOOK" VALUE FROM 100,00 TO 60,000 NG CEA/ML

    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