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    K Number
    K043031
    Device Name
    SERIM DIALYSATE MONITOR TEST STRIP
    Manufacturer
    SERIM RESEARCH CORP.
    Date Cleared
    2005-06-13

    (222 days)

    Product Code
    NTZ
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    NTZ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Serim™ Dialysate Monitor™ Test Strip provides semi-quantitative indications of pH, bicarbonate, and glucose (which acts as a tracer for the acid concentrate) concentrations in final bicarbonate dialysate solutions. They can be used to monitor the proper preparation of such dialysate solutions. The Serim™ Dialysate Monitor™ Test Strips are to be used to supplement current methods for testing dialysate.
    Device Description
    SERIM Dialysate Monitor Test Strips are firm plastic strips that contain three reagent areas to test for pH, bicarbonate/carbonate ion, and glucose in dialysate. The glucose concentration is a tracer of the amount of acid concentrate added to the dialysate.
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