BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM

    K Number: K991156 · Decision May 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    51

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    Basic Information

    Device Name
    GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM
    K Number
    K991156
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1820
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Great Smokies Diagnostic Laboratory
    Date Received
    April 7, 1999
    Decision Date
    May 28, 1999
    Product Code
    JOC
    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
    JOC Colorimetric, Xylose