BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Radioimmunoassay For Cyclosporine

    PMA: P890065 · Supplement: S001 · Decision Jan 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Radioimmunoassay For Cyclosporine
    Trade Name
    1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS
    PMA Number
    P890065
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    MGV
    Generic Name
    RADIOIMMUNOASSAY FOR CYCLOSPORINE
    Regulation Number
    862.1235
    Medical Specialty
    Clinical Chemistry
    Advisory Committee
    Clinical Toxicology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 30, 1991
    Date Received
    October 10, 1990
    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
    MGV Radioimmunoassay For Cyclosporine