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

    GENPRIME DRUGS OF ABUSE READER SYSTEM

    K Number: K130082 · Decision Dec 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    224
    Applicant Total
    2
    Review Days
    340

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    Basic Information

    Device Name
    GENPRIME DRUGS OF ABUSE READER SYSTEM
    K Number
    K130082
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genprime, Inc.
    Date Received
    January 14, 2013
    Decision Date
    December 20, 2013
    Product Code
    DKZ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DKZ Enzyme Immunoassay, Amphetamine

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