BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SOMAS LIQUID URINE CONTROL

    K Number: K862179 · Decision Jul 1, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    6
    Review Days
    22

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    Basic Information

    Device Name
    SOMAS LIQUID URINE CONTROL
    K Number
    K862179
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Somas Medical Industries, Inc.
    Date Received
    June 9, 1986
    Decision Date
    July 1, 1986
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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    Other Clearances by Somas Medical Industries, Inc.

    K Number Device Name
    K842134 SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY
    K840486 TOTAL BILIRUBIN REAGENT
    K840974 SOMAS HUMAN SPINAL FLUID CONTROL
    K840485 TOTAL IRON UIBC/TIBC ASSAY
    K833787 SOMAS CHLORIDE ASSAY KIT