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

    DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS

    K Number: K081378 · Decision Jan 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    62
    Applicant Total
    64
    Review Days
    243

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    Basic Information

    Device Name
    DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
    K Number
    K081378
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3620
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermo Fisher Scientific
    Date Received
    May 16, 2008
    Decision Date
    January 14, 2009
    Product Code
    DJR
    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
    DJR Enzyme Immunoassay, Methadone

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