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

    OHC COVID-19 Antigen Self Test

    K Number: K241313 · Decision May 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    386

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    Basic Information

    Device Name
    OHC COVID-19 Antigen Self Test
    K Number
    K241313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3984
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osang, LLC
    Date Received
    May 9, 2024
    Decision Date
    May 30, 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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    Other Clearances by Osang, LLC

    K Number Device Name
    K243262 QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test