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

    UV URIC ACID DETERMINATION

    K Number: K790834 · Decision Jun 28, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    30
    Applicant Total
    26
    Review Days
    59

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    Basic Information

    Device Name
    UV URIC ACID DETERMINATION
    K Number
    K790834
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    The Dow Chemical Co.
    Date Received
    April 30, 1979
    Decision Date
    June 28, 1979
    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 The Dow Chemical Co.

    K Number Device Name
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    K821315 DOWFLOW ENZYMATIC TRIGLYCERIDES DETERM
    K820675 BILIRUBIN(TOTAL) DETERMINATION CTMS
    K820714 DOW BILIRUBIN(DIRECT) DETERMINATION
    K812777 DIRECT IRON REAGENT SET
    K811806 QUICK-CHEM COLORIMETER
    K810861 CREATINE KINASE MB ISOENZYME IMMUNO UV
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