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

    CREATINE KINASE (CK-NAC)

    K Number: K013912 · Decision Jan 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    122
    Applicant Total
    20
    Review Days
    52

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    Basic Information

    Device Name
    CREATINE KINASE (CK-NAC)
    K Number
    K013912
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1215
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jas Diagnostics, Inc.
    Date Received
    November 27, 2001
    Decision Date
    January 18, 2002
    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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    K080618 DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
    K022519 LDL CHOLESTEROL (AUTOMATED)
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    K020454 CHEMISTRY CALIBRATOR
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    K013698 AST (SGOT)
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