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

    MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB

    K Number: K022654 · Decision Aug 29, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    264
    Review Days
    20

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    Basic Information

    Device Name
    MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
    K Number
    K022654
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Roche Diagnostics Corp.
    Date Received
    August 9, 2002
    Decision Date
    August 29, 2002
    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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