BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Enzyme Immunoassay, Cannabinoids

    PMA: P950040 · Decision Jan 21, 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
    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
    January 21, 1997
    Date Received
    December 19, 1995
    Expedited Review
    N
    Docket Number
    97M-0257

    Advisory Committee Statement

    APPROVAL FOR DR. BROWN'S HOME DRUG TESTING SYSTEM. DR. BROWN'S HOME DRUG TESTING SYSTEM IS AN OVER-THE-COUNTER COLLECTION AND TRANSPORT SYSTEM INTENDED FOR USE BY INDIVIDUALS WISHING TO ANONYMOUSLY TEST URINE SAMPLES FOR DRUGS OF ABUSE (MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, PHYENCYCLIDINE (PCP), CODEINE, AND MORPHINE).

    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