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

    BUN REAGENT KIT

    K Number: K800071 · Decision Feb 5, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    14
    Applicant Total
    89
    Review Days
    25

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    Basic Information

    Device Name
    BUN REAGENT KIT
    K Number
    K800071
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Fisher Scientific Co., LLC
    Date Received
    January 11, 1980
    Decision Date
    February 5, 1980
    Product Code
    CDS
    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
    CDS Electrode, Ion Specific, Urea Nitrogen

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