BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test

    K Number: K171247 · Decision Jan 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    14
    Applicant Total
    7
    Review Days
    264

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    Basic Information

    Device Name
    epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
    K Number
    K171247
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epocal, Inc.
    Date Received
    April 28, 2017
    Decision Date
    January 17, 2018
    Product Code
    CDS
    Advisory Committee
    Clinical Chemistry
    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
    CDS Electrode, Ion Specific, Urea Nitrogen

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