BEUDAMED
    Product Code: JOC FDA class 1 21 CFR 862.1820

    Colorimetric, Xylose

    Clinical Chemistry

    The Colorimetric, Xylose test is a clinical chemistry diagnostic device used to measure D-xylose in blood or urine by colorimetric methods, typically as part of the D-xylose absorption test to assess small intestinal absorptive function. Reduced xylose excretion is indicative of intestinal malabsorption. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JOC and is regulated under 21 CFR 862.1820, within the Clinical Chemistry medical specialty.

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    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    JOC
    Device Class
    FDA class 1
    Regulation Number
    862.1820
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K991156 GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.