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

    OralTox Oral Fluid Drug Test

    K Number: K171403 · Decision Feb 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    30
    Applicant Total
    2
    Review Days
    266

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    Basic Information

    Device Name
    OralTox Oral Fluid Drug Test
    K Number
    K171403
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Premier Biotech, Inc.
    Date Received
    May 12, 2017
    Decision Date
    February 2, 2018
    Product Code
    DJC
    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
    DJC Thin Layer Chromatography, Methamphetamine

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    Other Clearances by Premier Biotech, Inc.

    K Number Device Name
    K181305 OralTox Oral fluid Drug Test