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

    ePlex Respiratory Pathogen Panel

    K Number: K163636 · Decision Jun 9, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    78
    Applicant Total
    7
    Review Days
    169

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    Basic Information

    Device Name
    ePlex Respiratory Pathogen Panel
    K Number
    K163636
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genmark Diagnostics, Incorporated
    Date Received
    December 22, 2016
    Decision Date
    June 9, 2017
    Product Code
    OCC
    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
    OCC Respiratory Virus Panel Nucleic Acid Assay System

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