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510(k) Data Aggregation

    K Number
    K043267
    Device Name
    POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
    Date Cleared
    2005-02-10

    (76 days)

    Product Code
    Regulation Number
    862.1600
    Why did this record match?
    Product Code :

    CEJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Randox Laboratories Ltd. Potassium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Potassium in serum. Potassium is determined enzymatically via Potassium dependant pyruvate kinase activity using phosphoenolpyruvate as substrate. The pyruvate formed reacts with NADH in the presence of LDH to form lactate and NAD. The corresponding decrease in absorbance at 340 nm is proportional to the potassium concentration. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. This Application Sheet has been developed for the Hitachi 704, 717, 902 and 911/912 Analysers and must be used by suitable qualified laboratory personnel under appropriate laboratory conditions. Randox Electrolyte Cal 1 and 2 are liquid calibrators for in vitro diagnostic use in the calibration of NA+, K+ and CL- electrodes on Hitachi systems ISE modules and Randox Enzymatic Potassium kit. The Randox Electrolyte Cal 1 and 2 must only be used by suitable qualified laboratory personnel under appropriate laboratory conditions.
    Device Description
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