BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Enzyme Immunoassay, Tracrolimus

    PMA: P970007 · Supplement: S001 · Decision Sep 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Enzyme Immunoassay, Tracrolimus
    Trade Name
    ABBOTT IMX TACROLIMUS II
    PMA Number
    P970007
    Supplement Number
    S001
    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 22, 1999
    Date Received
    September 17, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for adding "Caution: This Product Contains Natural Dry Rubber" to the labeling.

    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