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

    LABONE MICRO-PLATE COTININE EIA

    K Number: K033601 · Decision Feb 10, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    122
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    LABONE MICRO-PLATE COTININE EIA
    K Number
    K033601
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3200
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Labone, Inc.
    Date Received
    November 14, 2003
    Decision Date
    February 10, 2004
    Product Code
    DLJ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    DLJ Calibrators, Drug Specific

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    Other Clearances by Labone, Inc.

    K Number Device Name
    K040198 LABONE COCAINE METABOLITE MICRO-PLATE EIA