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

    ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT

    K Number: K141265 · Decision Jul 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    17
    Review Days
    64

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    Basic Information

    Device Name
    ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
    K Number
    K141265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elitechgroup
    Date Received
    May 15, 2014
    Decision Date
    July 18, 2014
    Product Code
    JHW
    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
    JHW U.V. Method, Cpk Isoenzymes

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