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

    CREATINE KINASE UV REAGENT SET

    K Number: K905588 · Decision Jan 17, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    26
    Applicant Total
    20
    Review Days
    35

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    Basic Information

    Device Name
    CREATINE KINASE UV REAGENT SET
    K Number
    K905588
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biochemical Trade, Inc.
    Date Received
    December 13, 1990
    Decision Date
    January 17, 1991
    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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