BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    URIC ACID TEST KIT

    K Number: K901001 · Decision May 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    117
    Applicant Total
    5
    Review Days
    82

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    Basic Information

    Device Name
    URIC ACID TEST KIT
    K Number
    K901001
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Elite Technology, Inc.
    Date Received
    March 2, 1990
    Decision Date
    May 23, 1990
    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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