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

    UREA NITROGEN REAGENT SET

    K Number: K813415 · Decision Dec 31, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    20
    Applicant Total
    26
    Review Days
    24

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    Basic Information

    Device Name
    UREA NITROGEN REAGENT SET
    K Number
    K813415
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Anco Medical Reagents & Assoc.
    Date Received
    December 7, 1981
    Decision Date
    December 31, 1981
    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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