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

    UV URIC ACID DETERMINATION

    K Number: K813244 · Decision Dec 8, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    30
    Applicant Total
    11
    Review Days
    20

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    Basic Information

    Device Name
    UV URIC ACID DETERMINATION
    K Number
    K813244
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biorent Diagnostic, Inc.
    Date Received
    November 18, 1981
    Decision Date
    December 8, 1981
    Product Code
    CDO
    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
    CDO Acid, Uric, Uricase (U.V.)

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    Other Clearances by Biorent Diagnostic, Inc.

    K Number Device Name
    K832747 ALBUMIN REAGENT SET
    K823060 HEMOGLOBIN REAGENT
    K823211 CK-UV REAGENT
    K822494 OPTIMIZED UV-GPT REAGENT SET
    K822493 OPTIMIZED UV-GOT REAGENT SET
    K822492 OPTIMIZED UV-LDH REAGENT SET
    K820768 COLORIMETRIC LDH REAGENT SET
    K820632 COLORIMETRIC URIC ACID REAGENT SET
    K813555 GLUCOSE ENZYME-COLOR REAGENT SET
    K811760 CHOLESTEROL DETERMINATION
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