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

    ULTRACHEM URIC ACID AIDH, #65047

    K Number: K821465 · Decision Jun 2, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    30
    Applicant Total
    62
    Review Days
    15

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    Basic Information

    Device Name
    ULTRACHEM URIC ACID AIDH, #65047
    K Number
    K821465
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Emd Chemicals, Inc.
    Date Received
    May 18, 1982
    Decision Date
    June 2, 1982
    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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