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

    DART CK-MB REAGENT SYSTEM

    K Number: K854708 · Decision Dec 30, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    101
    Review Days
    38

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    Basic Information

    Device Name
    DART CK-MB REAGENT SYSTEM
    K Number
    K854708
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Coulter Electronics, Inc.
    Date Received
    November 22, 1985
    Decision Date
    December 30, 1985
    Product Code
    JHS
    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
    JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes

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