BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Enzyme Immunoassay, Tracrolimus

    PMA: P970007 · Supplement: S004 · Decision Sep 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Enzyme Immunoassay, Tracrolimus
    Trade Name
    IMX TACROLIMUS II
    PMA Number
    P970007
    Supplement Number
    S004
    Device Class
    FDA Class 2
    Product Code
    MLM
    Generic Name
    ENZYME IMMUNOASSAY, TRACROLIMUS
    Regulation Number
    862.1678
    Medical Specialty
    Clinical Chemistry
    Advisory Committee
    Clinical Toxicology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 5, 2002
    Date Received
    July 30, 2001
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF TESTING OF MODEL 1 CALIBRATOR TO VERIFY THE PROPER FILLING OF THE CALIBRATOR.

    Classifications

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

    Product Code Device Name
    MLM Enzyme Immunoassay, Tracrolimus