BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    FRONTLINE CANNABIS

    K Number: K954497 · Decision Mar 6, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    111
    Same Product Code
    149
    Applicant Total
    340
    Review Days
    161

    Basic Information

    Device Name
    FRONTLINE CANNABIS
    K Number
    K954497
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BOEHRINGER MANNHEIM CORP.
    Date Received
    September 27, 1995
    Decision Date
    March 6, 1996
    Product Code
    LDJ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LDJ Enzyme Immunoassay, Cannabinoids

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