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

    BUN-300/BUN-500 UREA NITROGEN REAGENT

    K Number: K934533 · Decision Nov 26, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    116
    Applicant Total
    7
    Review Days
    70

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    Basic Information

    Device Name
    BUN-300/BUN-500 UREA NITROGEN REAGENT
    K Number
    K934533
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Horizon Diagnostics, Inc.
    Date Received
    September 17, 1993
    Decision Date
    November 26, 1993
    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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