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

    COBAS REAGENT FOR BUN

    K Number: K801116 · Decision Jun 17, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    116
    Applicant Total
    11
    Review Days
    36

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    Basic Information

    Device Name
    COBAS REAGENT FOR BUN
    K Number
    K801116
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Roche Analytical Instruments, Inc.
    Date Received
    May 12, 1980
    Decision Date
    June 17, 1980
    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 Roche Analytical Instruments, Inc.

    K Number Device Name
    K801299 COBAS CK-NAC REAGENT
    K801298 COBAS REAGENT FOR TRIGLYCERIDES & COBAS
    K801295 COBAS REAGENT FOR A-AMYLASE
    K801297 COBAS REAGENT FOR GLUCOSE RAPID
    K801296 COBAS REAGENT FOR CHOLESTEROL
    K801243 COBAS REAGENTS FOR URIC ACID
    K801242 COBAS REAGENT FOR ALKALINE PHOSPHATASE
    K801118 COBAS REAGENT FOR AST (SGOT)
    K801119 COBAS REAGENT FOR ALT (GPT)
    K801117 COBAS TOTAL BILIRUBIN REAGENT & DILUENT
    Search all 11 clearances from Roche Analytical Instruments, Inc. →