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

    BUN-COLOR 2, BLOOD UREA NITROGEN TEST

    K Number: K800902 · Decision Jun 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    15
    Applicant Total
    82
    Review Days
    52

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    Basic Information

    Device Name
    BUN-COLOR 2, BLOOD UREA NITROGEN TEST
    K Number
    K800902
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Sclavo, Inc.
    Date Received
    April 18, 1980
    Decision Date
    June 9, 1980
    Product Code
    CDL
    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
    CDL Berthelot Indophenol, Urea Nitrogen

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