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

    UREA NITROGEN, KINETIC

    K Number: K810087 · Decision Feb 26, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    10
    Applicant Total
    19
    Review Days
    44

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    Basic Information

    Device Name
    UREA NITROGEN, KINETIC
    K Number
    K810087
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Bio-Analytics Laboratories, Inc.
    Date Received
    January 13, 1981
    Decision Date
    February 26, 1981
    Product Code
    JGZ
    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
    JGZ O-Phthalaldehyde, Urea Nitrogen

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