BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Cyclosporine

    PMA: P920031 · Supplement: S002 · Decision Feb 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Cyclosporine
    Trade Name
    COBAS INTEGRA CYCLOSPORINE
    PMA Number
    P920031
    Supplement Number
    S002
    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
    February 26, 2002
    Date Received
    February 20, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO EXPAND THE USE OF THE COBAS INTEGRA CYCLOSPORING REAGENT SYSTEM TO THE COBAS INTEGRA 400 AND COBAS INTEGRA 800 ANALYZERS.

    Classifications

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

    Product Code Device Name
    MKW Cyclosporine