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

    BinaxNOW COVID-19 Ag Card

    K Number: K250273 · Decision Jun 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    8
    Applicant Total
    6
    Review Days
    134

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    Basic Information

    Device Name
    BinaxNOW COVID-19 Ag Card
    K Number
    K250273
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    866.3982
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Diagnostics Scarborough, Inc.
    Date Received
    January 30, 2025
    Decision Date
    June 13, 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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    Other Clearances by Abbott Diagnostics Scarborough, Inc.

    K Number Device Name
    K243518 BinaxNOW™ COVID-19 Antigen Self Test
    K232775 ID NOW Influenza A & B 2
    K221925 ID NOW COVID-19 2.0
    K220801 ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
    K191534 ID NOW Influenza A & B 2