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

    Cyclosporine

    PMA: P920031 · Decision Oct 2, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Cyclosporine
    Trade Name
    EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
    PMA Number
    P920031
    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 (Reclassification)
    Decision Code
    APRL
    Decision Date
    October 2, 1996
    Date Received
    June 29, 1992
    Expedited Review
    N
    Docket Number
    97M-0082

    Advisory Committee Statement

    APPROVAL FOR THE EMIT(R) 2000 CYCLOSPORINE SPECIFIC ASSAY. THE DEVICE IS INDICATED FOR IN VITRO DIAGNOSTIC USE ON THE ROCHE DIAGNOSTICS SYSTEMS COBAS MIRA, COBAS MIRA S, AND COBAS MIRA PLUS CHEMISTRY SYSTEMS FOR THE QUANTITATIVE ANALYSIS OF CYCLOSPORINE (CSA) IN HUMAN 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