BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Assay, Estrogen Receptor

    PMA: P860015 · Supplement: S001 · Decision Apr 21, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Kit, Assay, Estrogen Receptor
    Trade Name
    FLUORO-CEP{R} ESTROGEN ASSAY REAGENT
    PMA Number
    P860015
    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
    April 21, 1992
    Date Received
    December 11, 1991
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    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