BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP

    K Number: K122718 · Decision Feb 6, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    43
    Applicant Total
    134
    Review Days
    154

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    Basic Information

    Device Name
    BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
    K Number
    K122718
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson and Company
    Date Received
    September 5, 2012
    Decision Date
    February 6, 2013
    Product Code
    GTY
    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
    GTY Antigens, All Groups, Streptococcus Spp.

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