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

    BinaxNOW™ COVID-19 Antigen Self Test

    K Number: K243518 · Decision Feb 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    13
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    BinaxNOW™ COVID-19 Antigen Self Test
    K Number
    K243518
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3984
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Diagnostics Scarborough, Inc.
    Date Received
    November 13, 2024
    Decision Date
    February 11, 2025
    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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    Other Clearances by Abbott Diagnostics Scarborough, Inc.

    K Number Device Name
    K250273 BinaxNOW COVID-19 Ag Card
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    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