BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Antigen, Cancer 549

    PMA: P950011 · Decision Mar 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Antigen, Cancer 549
    Trade Name
    TRUQUANT(R) BR(TM) RIA
    PMA Number
    P950011
    Device Class
    FDA Class 3
    Product Code
    MJB
    Generic Name
    ANTIGEN, CANCER 549
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 29, 1996
    Date Received
    February 28, 1995
    Expedited Review
    Y
    Docket Number
    96M-0216

    Advisory Committee Statement

    APPROVAL FOR AN IN VITRO DIAGNOSITC DEVICE (BIOMIRA TRUQUANT BR RIA)

    Classifications

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

    Product Code Device Name
    MJB Antigen, Cancer 549