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

    BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit

    K Number: K152870 · Decision Oct 27, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    71
    Applicant Total
    6
    Review Days
    27

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    Basic Information

    Device Name
    BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit
    K Number
    K152870
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3328
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson and Co.
    Date Received
    September 30, 2015
    Decision Date
    October 27, 2015
    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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