BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Assay, Estrogen Receptor

    PMA: P800061 · Supplement: S007 · Decision Mar 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Kit, Assay, Estrogen Receptor
    Trade Name
    RIANEN 3H
    PMA Number
    P800061
    Supplement Number
    S007
    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
    March 26, 1985
    Date Received
    June 14, 1984
    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