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

    STATTEK BUN

    K Number: K792328 · Decision Dec 18, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    15
    Applicant Total
    340
    Review Days
    29

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    Basic Information

    Device Name
    STATTEK BUN
    K Number
    K792328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Boehringer Mannheim Corp.
    Date Received
    November 19, 1979
    Decision Date
    December 18, 1979
    Product Code
    CDN
    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
    CDN Urease, Photometric, Urea Nitrogen

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