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

    ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

    K Number: K182619 · Decision Apr 12, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    10
    Applicant Total
    7
    Review Days
    200

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    Basic Information

    Device Name
    ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
    K Number
    K182619
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3365
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genmark Diagnostics, Incorporated
    Date Received
    September 24, 2018
    Decision Date
    April 12, 2019
    Product Code
    PEN
    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
    PEN Gram-Negative Bacteria And Associated Resistance Markers

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    Other Clearances by Genmark Diagnostics, Incorporated

    K Number Device Name
    K213236 ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
    K182690 ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
    K181663 ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
    K163636 ePlex Respiratory Pathogen Panel
    K163652 ePlex Instrument
    K152612 eSensor Warfarin Sensitivity Saliva Test