BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Enzyme Immunoassay, Cannabinoids

    PMA: P950040 · Supplement: S003 · Decision Aug 15, 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
    S003
    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
    August 15, 1997
    Date Received
    June 10, 1997
    Expedited Review
    N

    Advisory Committee Statement

    Approval for labeling of your device in final printed form and for a change in the group providing phone services related to your device from Joseph J. Sheerin to National Medical Review Officers, Inc.

    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