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

    CREATININE

    K Number: K061193 · Decision Jun 23, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    158
    Applicant Total
    6
    Review Days
    56

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    Basic Information

    Device Name
    CREATININE
    K Number
    K061193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Laboratories, Inc.
    Date Received
    April 28, 2006
    Decision Date
    June 23, 2006
    Product Code
    CGX
    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
    CGX Alkaline Picrate, Colorimetry, Creatinine

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