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

    Labcorp Fentanyl Urine Visual Test

    K Number: K252684 · Decision Jan 29, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    100
    Registration Numbers
    100
    Same Product Code
    214
    Applicant Total
    22
    Review Days
    157

    Basic Information

    Device Name
    Labcorp Fentanyl Urine Visual Test
    K Number
    K252684
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3650
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtox Diagnostics, Inc.
    Date Received
    August 25, 2025
    Decision Date
    January 29, 2026
    Product Code
    DJG
    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
    DJG Enzyme Immunoassay, Opiates

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    Other Clearances by Medtox Diagnostics, Inc.

    K Number Device Name
    K100951 MEDTOX BUPRENORPHINE TEST
    K100023 PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM
    K091454 PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM
    K080635 MEDTOXSCAN
    K060351 MEDTOX OXYCODONE
    K050394 SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS
    K033334 PROFILE -ER
    K031032 VERDICT II, PROFILE II
    K022141 VERDICT-II
    K020787 VERDICT-II PROPOXYPHENE
    Search all 22 clearances from Medtox Diagnostics, Inc. →