BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    High Performance Liquid Chromatography For Cyclosporine

    PMA: P880032 · Supplement: S002 · Decision Mar 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    High Performance Liquid Chromatography For Cyclosporine
    Trade Name
    BIO-RAD CYCLOSPORINE BY HPLC TEST
    PMA Number
    P880032
    Supplement Number
    S002
    Device Class
    FDA Class 2
    Product Code
    MGS
    Generic Name
    HIGH PERFORMANCE LIQUID CHROMATOGRAPHY FOR CYCLOSPORINE
    Regulation Number
    862.1235
    Medical Specialty
    Clinical Chemistry
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 1, 1996
    Date Received
    March 16, 1993
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN MANUFACTURER SITE OF THE ANALYTICAL CARTRIDGE FROM THE LIFE SCIENCE GROUP OF BIO-RAD LABORATORIES LOCATED IN RICHMOND, CA TO THE CLINICAL SYSTEMS DIVISION OF THE DIAGNOSTICS GROUP OF BIO-RAD LABORATORIES LOCATED IN HERCULES, CA., AND CHANGING THE VENDOR OF THE "CLEAN UP" COLUMNS FOR THE CYCLOSPORIN TEST BY HPLC

    Classifications

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

    Product Code Device Name
    MGS High Performance Liquid Chromatography For Cyclosporine