BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Test System, For Drugs Of Abuse

    PMA: P900042 · Decision Jan 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Test System, For Drugs Of Abuse
    Trade Name
    AWARE TEST SYSTEM
    PMA Number
    P900042
    Device Class
    FDA Class 3
    Product Code
    MGX
    Generic Name
    TEST SYSTEM, FOR DRUGS OF ABUSE
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 18, 1994
    Date Received
    June 15, 1990
    Expedited Review
    N
    Docket Number
    94M-0067

    Classifications

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

    Product Code Device Name
    MGX Test System, For Drugs Of Abuse