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

    EasyLyte Na/K/Cl/Ca Analyzer

    K Number: K152327 · Decision Dec 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    28
    Applicant Total
    7
    Review Days
    471

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    Basic Information

    Device Name
    EasyLyte Na/K/Cl/Ca Analyzer
    K Number
    K152327
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1145
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medica Corporation
    Date Received
    August 18, 2015
    Decision Date
    December 1, 2016
    Product Code
    JFP
    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
    JFP Electrode, Ion Specific, Calcium

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