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

    SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY

    K Number: K842134 · Decision Jul 6, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    12
    Applicant Total
    6
    Review Days
    37

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    Basic Information

    Device Name
    SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY
    K Number
    K842134
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1635
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Somas Medical Industries, Inc.
    Date Received
    May 30, 1984
    Decision Date
    July 6, 1984
    Product Code
    JGQ
    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
    JGQ Turbidimetric, Total Protein

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    Other Clearances by Somas Medical Industries, Inc.

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    K862179 SOMAS LIQUID URINE CONTROL
    K840486 TOTAL BILIRUBIN REAGENT
    K840974 SOMAS HUMAN SPINAL FLUID CONTROL
    K840485 TOTAL IRON UIBC/TIBC ASSAY
    K833787 SOMAS CHLORIDE ASSAY KIT