BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Cyclosporine

    PMA: P920031 · Supplement: S003 · Decision Jul 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Cyclosporine
    Trade Name
    COBAS INTEGRA 400 PLUS CYCLOSPORINE
    PMA Number
    P920031
    Supplement Number
    S003
    Device Class
    FDA Class 2
    Product Code
    MKW
    Generic Name
    CYCLOSPORINE
    Regulation Number
    862.1235
    Medical Specialty
    Clinical Chemistry
    Advisory Committee
    Clinical Toxicology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 24, 2002
    Date Received
    May 17, 2002
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR EXPANDING THE USE OF THE COBAS INTEGRA CYCLOSPORINE REAGENT TO THE COBAS INTEGRA 400 PLUS ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS INTEGRA CYCLOSPORINE AND IS INDICATED FOR QUANTITATIVE DETERMINATION OF CYCLOSPORINE IN WHOLE BLOOD AS AN AID IN THE MANAGEMENT OF CYCLOSPORINE THERAPY IN KIDNEY, HEART AND LIVER TRANSPLANT PATIENTS.

    Classifications

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

    Product Code Device Name
    MKW Cyclosporine