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

    Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

    K Number: K241317 · Decision Sep 30, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    13
    Applicant Total
    43
    Review Days
    143

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    Basic Information

    Device Name
    Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
    K Number
    K241317
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3984
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Wondfo Biotech Co., Ltd.
    Date Received
    May 10, 2024
    Decision Date
    September 30, 2024
    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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