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

    Xpert Xpress Strep A

    K Number: K172126 · Decision Sep 25, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    13
    Applicant Total
    50
    Review Days
    73

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    Basic Information

    Device Name
    Xpert Xpress Strep A
    K Number
    K172126
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2680
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cepheid
    Date Received
    July 14, 2017
    Decision Date
    September 25, 2017
    Product Code
    PGX
    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
    PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

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