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

    URIC ACID TEST

    K Number: K864119 · Decision Oct 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    117
    Applicant Total
    22
    Review Days
    8

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    Basic Information

    Device Name
    URIC ACID TEST
    K Number
    K864119
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    U. S. Diagnostics, Inc.
    Date Received
    October 21, 1986
    Decision Date
    October 29, 1986
    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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