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

    TOTAL BILIRUBIN REAGENT

    K Number: K840486 · Decision Apr 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    234
    Applicant Total
    6
    Review Days
    79

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    Basic Information

    Device Name
    TOTAL BILIRUBIN REAGENT
    K Number
    K840486
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1110
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Somas Medical Industries, Inc.
    Date Received
    February 6, 1984
    Decision Date
    April 25, 1984
    Product Code
    CIG
    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
    CIG Diazo Colorimetry, Bilirubin

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    Other Clearances by Somas Medical Industries, Inc.

    K Number Device Name
    K862179 SOMAS LIQUID URINE CONTROL
    K842134 SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY
    K840974 SOMAS HUMAN SPINAL FLUID CONTROL
    K840485 TOTAL IRON UIBC/TIBC ASSAY
    K833787 SOMAS CHLORIDE ASSAY KIT