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

    IL TEST CK-MB

    K Number: K952646 · Decision Aug 4, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    122
    Applicant Total
    321
    Review Days
    56

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    Basic Information

    Device Name
    IL TEST CK-MB
    K Number
    K952646
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instrumentation Laboratory CO
    Date Received
    June 9, 1995
    Decision Date
    August 4, 1995
    Product Code
    CGS
    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
    CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

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