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

    QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test

    K Number: K243262 · Decision Jan 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test
    K Number
    K243262
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3987
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osang, LLC
    Date Received
    October 15, 2024
    Decision Date
    January 13, 2025
    Product Code
    SCA
    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
    SCA Multi-Analyte Respiratory Virus Antigen Detection Test

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    Other Clearances by Osang, LLC

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