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

    Sober Self-Test

    K Number: K250609 · Decision Sep 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    32
    Applicant Total
    1
    Review Days
    199

    Basic Information

    Device Name
    Sober Self-Test
    K Number
    K250609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3040
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sober Ip, LLC
    Date Received
    February 28, 2025
    Decision Date
    September 15, 2025
    Product Code
    DIC
    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
    DIC Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

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