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

    BLOOD UREA NITROGEN REAGENT SYSTEM

    K Number: K952742 · Decision Aug 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    116
    Applicant Total
    57
    Review Days
    56

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    Basic Information

    Device Name
    BLOOD UREA NITROGEN REAGENT SYSTEM
    K Number
    K952742
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Diagnostic Technologies, Inc.
    Date Received
    June 16, 1995
    Decision Date
    August 11, 1995
    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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