BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET

    K Number: K062593 · Decision Nov 22, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    672
    Applicant Total
    2
    Review Days
    82

    Basic Information

    Device Name
    CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET
    K Number
    K062593
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    COMPASS BIOSCIENCE
    Date Received
    September 1, 2006
    Decision Date
    November 22, 2006
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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