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

    Fluorescence Polarization Immunoassay For Cyclosporine

    PMA: P890025 · Decision Dec 14, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Fluorescence Polarization Immunoassay For Cyclosporine
    Trade Name
    TD CYCLOSPORINE AND METABOLITES SERUM ASSAY
    PMA Number
    P890025
    Device Class
    FDA Class 2
    Product Code
    MGU
    Generic Name
    Fluorescence polarization immunoassay for cyclosporine
    Regulation Number
    862.1235
    Medical Specialty
    Clinical Chemistry
    Advisory Committee
    Clinical Toxicology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    December 14, 1989
    Date Received
    April 10, 1989
    Expedited Review
    N
    Docket Number
    89M-0523

    Classifications

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

    Product Code Device Name
    MGU Fluorescence Polarization Immunoassay For Cyclosporine