BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Radioimmunoassay For Cyclosporine

    PMA: P890065 · Decision Sep 28, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Radioimmunoassay For Cyclosporine
    Trade Name
    CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS
    PMA Number
    P890065
    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 (Reclassification)
    Decision Code
    APRL
    Decision Date
    September 28, 1990
    Date Received
    November 17, 1989
    Expedited Review
    N
    Docket Number
    90M-0444

    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