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

    SYSTEMATE CREATININE 67223

    K Number: K843105 · Decision Aug 27, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    158
    Applicant Total
    288
    Review Days
    20

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    Basic Information

    Device Name
    SYSTEMATE CREATININE 67223
    K Number
    K843105
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    August 7, 1984
    Decision Date
    August 27, 1984
    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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