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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Kit, Assay, Progesterone Receptor

    PMA: P920006 · Decision Sep 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Kit, Assay, Progesterone Receptor
    Trade Name
    IMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE
    PMA Number
    P920006
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 26, 1995
    Date Received
    February 6, 1992
    Expedited Review
    N
    Docket Number
    96M-0219

    Advisory Committee Statement

    APPROVAL FOR THE ABBOTT PGR-ICA MONOCLONAL

    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