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

    Nano-Check Influenza A+B Test

    K Number: K252283 · Decision Jan 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    71
    Applicant Total
    6
    Review Days
    177

    Basic Information

    Device Name
    Nano-Check Influenza A+B Test
    K Number
    K252283
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    866.3328
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nano-Ditech Corporation
    Date Received
    July 22, 2025
    Decision Date
    January 15, 2026
    Product Code
    PSZ
    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
    PSZ Devices Detecting Influenza A, B, And C Virus Antigens

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