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

    FERMCOTEST R BUN RATE REAGENT TEST KIT

    K Number: K791018 · Decision Jul 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    14
    Applicant Total
    8
    Review Days
    46

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    Basic Information

    Device Name
    FERMCOTEST R BUN RATE REAGENT TEST KIT
    K Number
    K791018
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Fermco Biochemics, Inc.
    Date Received
    June 1, 1979
    Decision Date
    July 17, 1979
    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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    K810567 GERMCO TEST R GLUCOSE TEST KIT
    K791066 GLUCOSE GOD-PAP TRINDER METHOD TEST KIT
    K781945 GLUCOSE OXIDASE REAGENT