BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Enzyme Immunoassay, Cannabinoids

    PMA: P950040 · Supplement: S002 · Decision Feb 5, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111

    Basic Information

    Device Name
    Enzyme Immunoassay, Cannabinoids
    Trade Name
    DR. BROWN'S HOME DRUG TESTING KIT
    PMA Number
    P950040
    Supplement Number
    S002
    Device Class
    FDA Class 2
    Product Code
    LDJ
    Generic Name
    Enzyme immunoassay, cannabinoids
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Advisory Committee
    Clinical Toxicology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 5, 1997
    Date Received
    February 5, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: CHANGING THE TESTING LABORATORY TO AMERICAL MEDICAL LABORATORY (AML); INCLUDING HEROIN TESTING AS PART OF THE TEST SYSTEM; AND REVISED LABELING IN ASSOCIATION WITH THE ADDED HEROIN TESTING.

    Classifications

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

    Product Code Device Name
    LDJ Enzyme Immunoassay, Cannabinoids