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

    eSensor Warfarin Sensitivity Saliva Test

    K Number: K152612 · Decision May 26, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    5
    Applicant Total
    7
    Review Days
    255

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    Basic Information

    Device Name
    eSensor Warfarin Sensitivity Saliva Test
    K Number
    K152612
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3360
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genmark Diagnostics, Incorporated
    Date Received
    September 14, 2015
    Decision Date
    May 26, 2016
    Product Code
    ODW
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ODW Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

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