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

    THE URIC ACID REAGENT SET

    K Number: K871902 · Decision Jun 3, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    117
    Applicant Total
    2
    Review Days
    19

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    Basic Information

    Device Name
    THE URIC ACID REAGENT SET
    K Number
    K871902
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Macomb Biotechnology, Inc.
    Date Received
    May 15, 1987
    Decision Date
    June 3, 1987
    Product Code
    KNK
    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
    KNK Acid, Uric, Uricase (Colorimetric)

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    Other Clearances by Macomb Biotechnology, Inc.

    K Number Device Name
    K894951 MODIFIED HEMOGLOBIN REAGENT SET