BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Cyclosporine Radioimmunoassay

    PMA: P850086 · Supplement: S001 · Decision Dec 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Cyclosporine Radioimmunoassay
    Trade Name
    SANDIMMUNE(R) RADIOIMMUNOASSAY KIT
    PMA Number
    P850086
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    LTB
    Generic Name
    CYCLOSPORINE RADIOIMMUNOASSAY
    Regulation Number
    862.1235
    Medical Specialty
    Clinical Chemistry
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 17, 1991
    Date Received
    March 26, 1990
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change in the polyclonal antibody to a monoclonal specific and a monoclonal non-specific antibody assay.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LTB Cyclosporine Radioimmunoassay