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

    GenPrime Snap-Top Split Key Cup

    K Number: K140665 · Decision Dec 8, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    2
    Review Days
    265

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    Basic Information

    Device Name
    GenPrime Snap-Top Split Key Cup
    K Number
    K140665
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genprime, Inc.
    Date Received
    March 18, 2014
    Decision Date
    December 8, 2014
    Product Code
    DIS
    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
    DIS Enzyme Immunoassay, Barbiturate

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    Other Clearances by Genprime, Inc.

    K Number Device Name
    K130082 GENPRIME DRUGS OF ABUSE READER SYSTEM