BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    OLYMPUS CK-MB REAGENT

    K Number: K070835 · Decision Jun 4, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    3
    Review Days
    69

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    Basic Information

    Device Name
    OLYMPUS CK-MB REAGENT
    K Number
    K070835
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Life & Material Science Europa GmbH (Irish
    Date Received
    March 27, 2007
    Decision Date
    June 4, 2007
    Product Code
    JHY
    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
    JHY Colorimetric Method, Cpk Or Isoenzymes

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    Other Clearances by Olympus Life & Material Science Europa GmbH (Irish

    K Number Device Name
    K070708 OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104
    K070453 OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL