BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Assay, Progesterone Receptor

    PMA: P820052 · Supplement: S008 · Decision Aug 6, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Kit, Assay, Progesterone Receptor
    Trade Name
    RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT
    PMA Number
    P820052
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    LPI
    Generic Name
    KIT, ASSAY, PROGESTERONE RECEPTOR
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 6, 1991
    Date Received
    February 15, 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
    LPI Kit, Assay, Progesterone Receptor