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

    UREA NITROGEN REAGENT

    K Number: K944250 · Decision Feb 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    116
    Applicant Total
    2
    Review Days
    160

    Basic Information

    Device Name
    UREA NITROGEN REAGENT
    K Number
    K944250
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    OLYMPUS CORP OF AMERICA
    Date Received
    September 1, 1994
    Decision Date
    February 8, 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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    Other Clearances by OLYMPUS CORP OF AMERICA

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