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

    ID NOW COVID-19 2.0

    K Number: K221925 · Decision Aug 10, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    405

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    Basic Information

    Device Name
    ID NOW COVID-19 2.0
    K Number
    K221925
    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
    July 1, 2022
    Decision Date
    August 10, 2023
    Product Code
    QWR
    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
    QWR Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

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