BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CK-MB ASSAY, CATALOGUE NUMBER 317-10

    K Number: K942773 · Decision Aug 24, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    122
    Applicant Total
    66
    Review Days
    72

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    Basic Information

    Device Name
    CK-MB ASSAY, CATALOGUE NUMBER 317-10
    K Number
    K942773
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diagnostic Chemicals , Ltd.
    Date Received
    June 13, 1994
    Decision Date
    August 24, 1994
    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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