BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

    PMA: P850009 · Supplement: S006 · Decision Mar 23, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
    Trade Name
    CA 125 ANTIBODY RIA
    PMA Number
    P850009
    Supplement Number
    S006
    Device Class
    FDA Class 2
    Product Code
    LTK
    Generic Name
    TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 23, 1994
    Date Received
    September 15, 1993
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)