BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Kit, Assay, Estrogen Receptor

    PMA: P850029 · Decision Oct 17, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Kit, Assay, Estrogen Receptor
    Trade Name
    ABBOTT ER-EIA MONOCLONAL DIAG. KIT
    PMA Number
    P850029
    Device Class
    FDA Class 3
    Product Code
    LPJ
    Generic Name
    KIT, ASSAY, ESTROGEN RECEPTOR
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    October 17, 1988
    Date Received
    May 17, 1985
    Expedited Review
    N
    Docket Number
    88M-0368

    Classifications

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

    Product Code Device Name
    LPJ Kit, Assay, Estrogen Receptor