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

    DIRECTIGEN 1-2-3 GROUP A STREP TEST

    K Number: K951542 · Decision Oct 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    104
    Applicant Total
    632
    Review Days
    200

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    Basic Information

    Device Name
    DIRECTIGEN 1-2-3 GROUP A STREP TEST
    K Number
    K951542
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    April 3, 1995
    Decision Date
    October 20, 1995
    Product Code
    GTZ
    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
    GTZ Antisera, All Groups, Streptococcus Spp.

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