BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CARESIDE BUN

    K Number: K980057 · Decision Feb 5, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    116
    Applicant Total
    9
    Review Days
    30

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    Basic Information

    Device Name
    CARESIDE BUN
    K Number
    K980057
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Exigent Diagnostics, Inc.
    Date Received
    January 6, 1998
    Decision Date
    February 5, 1998
    Product Code
    CDQ
    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
    CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

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