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

    GenaCheck COVID-19 Rapid Self-Test

    K Number: K251753 · Decision Sep 5, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    88

    Basic Information

    Device Name
    GenaCheck COVID-19 Rapid Self-Test
    K Number
    K251753
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3984
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genabio Diagnostics, Inc.
    Date Received
    June 9, 2025
    Decision Date
    September 5, 2025
    Product Code
    QYT
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QYT Over-The-Counter Covid-19 Antigen Test

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