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

    Xpert VanA Assay

    K Number: K092953 · Decision Dec 17, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    50
    Review Days
    84

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    Basic Information

    Device Name
    Xpert VanA Assay
    K Number
    K092953
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cepheid
    Date Received
    September 24, 2009
    Decision Date
    December 17, 2009
    Product Code
    NIJ
    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
    NIJ System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

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