BEUDAMED
    Product Code: JHC FDA class 1 21 CFR 862.1775

    Acid, Uric, Uricase (Oxygen Rate)

    Clinical Chemistry

    Uric Acid by Uricase (Oxygen Rate) is a clinical chemistry test system that measures the rate of oxygen consumption during the uricase-catalyzed oxidation of uric acid, providing quantitative uric acid levels in blood or urine for gout and renal function assessment. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is JHC, regulated under 21 CFR 862.1775, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    JHC
    Device Class
    FDA class 1
    Regulation Number
    862.1775
    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
    K863287 URIC ACID (URICASE) METHOD-II

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.