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

    SOMAS HUMAN SPINAL FLUID CONTROL

    K Number: K840974 · Decision Apr 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    3
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    SOMAS HUMAN SPINAL FLUID CONTROL
    K Number
    K840974
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5860
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Somas Medical Industries, Inc.
    Date Received
    March 6, 1984
    Decision Date
    April 5, 1984
    Product Code
    DFI
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DFI Total Spinal-Fluid, Antigen, Antiserum, Control

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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
    K840486 TOTAL BILIRUBIN REAGENT
    K840485 TOTAL IRON UIBC/TIBC ASSAY
    K833787 SOMAS CHLORIDE ASSAY KIT