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

    Nano-Check™ COVID-19 Antigen Test

    K Number: K231187 · Decision Jan 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    8
    Applicant Total
    6
    Review Days
    272

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    Basic Information

    Device Name
    Nano-Check™ COVID-19 Antigen Test
    K Number
    K231187
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3982
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nano-Ditech Corporation
    Date Received
    April 26, 2023
    Decision Date
    January 23, 2024
    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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