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

    COULTER CK-MB ISOENZYME REAGENT

    K Number: K904866 · Decision Dec 13, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    20
    Applicant Total
    101
    Review Days
    45

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    Basic Information

    Device Name
    COULTER CK-MB ISOENZYME REAGENT
    K Number
    K904866
    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
    October 29, 1990
    Decision Date
    December 13, 1990
    Product Code
    JHT
    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
    JHT Chromatographic Separation, Cpk Isoenzymes

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