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

    WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest

    K Number: K243256 · Decision Jan 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    93

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest
    K Number
    K243256
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3987
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wondfo USA Co, Ltd.
    Date Received
    October 15, 2024
    Decision Date
    January 16, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (SCA), ordered by most recent decision date.

    iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro

    FDA 510(k)
    FDA Class 2 ·Microbiology

    iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Status™ COVID-19/Flu A&B

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Flowflex Plus RSV + Flu A/B + COVID Home Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CareSuperb COVID-19/Flu A&B Antigen Combo Home Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Wondfo USA Co, Ltd.

    K Number Device Name
    K251563 WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test