BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    WELLlife COVID-19 Antigen Test Rx

    K Number: K251289 · Decision Oct 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    8
    Applicant Total
    43
    Review Days
    180

    Basic Information

    Device Name
    WELLlife COVID-19 Antigen Test Rx
    K Number
    K251289
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    866.3982
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Received
    April 25, 2025
    Decision Date
    October 22, 2025
    Product Code
    QVF
    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
    QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

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