BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    RANDOX URIC ACID

    K Number: K033278 · Decision Feb 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    30
    Applicant Total
    116
    Review Days
    140

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    Basic Information

    Device Name
    RANDOX URIC ACID
    K Number
    K033278
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Randox Laboratories, Ltd.
    Date Received
    October 10, 2003
    Decision Date
    February 27, 2004
    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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