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

    Accula Flu A/Flu B Test

    K Number: K171641 · Decision Feb 6, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    19
    Applicant Total
    3
    Review Days
    249

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    Basic Information

    Device Name
    Accula Flu A/Flu B Test
    K Number
    K171641
    Device Class
    FDA class 2
    Clearance Type
    Dual Track
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mesa Biotech, Inc.
    Date Received
    June 2, 2017
    Decision Date
    February 6, 2018
    Product Code
    OZE
    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
    OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay

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    Other Clearances by Mesa Biotech, Inc.

    K Number Device Name
    K201269 Accula Strep A Test
    K181443 Accula RSV Test