BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Assay, Estrogen Receptor

    PMA: P850029 · Supplement: S001 · Decision Jul 12, 1995
    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
    Supplement Number
    S001
    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
    Decision Code
    APPR
    Decision Date
    July 12, 1995
    Date Received
    May 25, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    MINOR LABELING CHGS TO ASSIST USERS TO AVOID INTERFERENCE BY METHYLENE BLUE & SIMILAR DYES.CHANGES:REVISED INSTRUCTIONS ON SPECIMEN COLLECTION & SLIDE PREPARATION, INSTRUCTIONS TO REPORT PRESENCE OR ABSENCE OF SURGICAL DYES

    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