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510(k) Data Aggregation

    K Number
    K043268
    Device Name
    SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2
    Date Cleared
    2005-02-15

    (81 days)

    Product Code
    Regulation Number
    862.1665
    Why did this record match?
    Product Code :

    CEI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Randox Sodium Test Kit: The Randox Laboratories Ltd. Sodium Test Kit is an in vitro diagnostic reagent for the quantitative determination of Sodium in serum. Sodium is determined enzymatically via Sodium dependant 9-galactosidase activity with ONPG as substrate. The absorbance at 405 nm of the product O-nitrophenyl is proportional to the sodium concentration. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hyper-tension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. 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: 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 Sodium 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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