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

    ELITECH CLINICAL SYSTEMS CK NAC SL

    K Number: K122083 · Decision Aug 22, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    17
    Review Days
    37

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    Basic Information

    Device Name
    ELITECH CLINICAL SYSTEMS CK NAC SL
    K Number
    K122083
    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
    July 16, 2012
    Decision Date
    August 22, 2012
    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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