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

    AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup

    K Number: K252259 · Decision Aug 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    29
    Applicant Total
    6
    Review Days
    25

    Basic Information

    Device Name
    AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup
    K Number
    K252259
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3100
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Assure Tech., LLC
    Date Received
    July 21, 2025
    Decision Date
    August 15, 2025
    Product Code
    NFT
    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
    NFT Test, Amphetamine, Over The Counter

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