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

    ePlex Instrument

    K Number: K163652 · Decision Jun 9, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    12
    Applicant Total
    7
    Review Days
    168

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    Basic Information

    Device Name
    ePlex Instrument
    K Number
    K163652
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.2570
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genmark Diagnostics, Incorporated
    Date Received
    December 23, 2016
    Decision Date
    June 9, 2017
    Product Code
    NSU
    Advisory Committee
    Clinical Chemistry
    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
    NSU Instrumentation For Clinical Multiplex Test Systems

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