BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Assay, Estrogen Receptor

    PMA: P850029 · Supplement: S002 · Decision Sep 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Kit, Assay, Estrogen Receptor
    Trade Name
    ER-EIA MONOCLONAL
    PMA Number
    P850029
    Supplement Number
    S002
    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
    September 22, 1999
    Date Received
    September 16, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for adding "Caution: This Product Contains Natural Dry Rubber" to labeling.

    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