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

    IQ URIC ACID TEST

    K Number: K864341 · Decision Dec 16, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    117
    Applicant Total
    632
    Review Days
    42

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    Basic Information

    Device Name
    IQ URIC ACID TEST
    K Number
    K864341
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    November 4, 1986
    Decision Date
    December 16, 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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