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

    BLOOD UREA NITROGEN BUN

    K Number: K771830 · Decision Oct 25, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    20
    Applicant Total
    23
    Review Days
    34

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    Basic Information

    Device Name
    BLOOD UREA NITROGEN BUN
    K Number
    K771830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Gamma Enterprises, Inc.
    Date Received
    September 21, 1977
    Decision Date
    October 25, 1977
    Product Code
    CDW
    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
    CDW Diacetyl-Monoxime, Urea Nitrogen

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