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

    Visby Medical Flu and COVID-19 Test

    K Number: K253971 · Decision May 27, 2026
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    167

    Basic Information

    Device Name
    Visby Medical Flu and COVID-19 Test
    K Number
    K253971
    Clearance Type
    Traditional
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Visby Medical, Inc.
    Date Received
    December 11, 2025
    Decision Date
    May 27, 2026
    Product Code
    SIA
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Other Clearances by Visby Medical, Inc.

    K Number Device Name
    K251501 Visby Medical Men's Sexual Health Test
    DEN240020 Visby Medical Women's Sexual Health Test
    K242526 Visby Medical Respiratory Health Test