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Lorraine Piestrak Re k031135 TradeDevice Name Glucose Flex reagent cartridge GLUC Regulation Number 2 1 CFR 862. 999 Urine -1. 05 1. ooo 1. OO -0. 54 n Conclusion The Glucose Flex reagent cartridge GLUC is substantially equivalent in principle and performance to the Glucose Flex reagent cartridge GLU assay based on the split sample comparison discussed above. Also please note the regulation entitled Misbranding by reference to premarket notification 2 lCFR Part 807. 92. Lorraine Piestrak -...

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