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Kathie Goodwin 11AY 1 22011 P0 Box 50416 Re k103716 Trade/Device Name Roche Elecsys Folate RBC Folate RBC CalCheck Folate RBC CalSet Regulation Number 21 CFR 862. The concentration of the diluted sample must be 3 10 ng/mL. Elecsys 2010/cobas e411 Repeatability Hemolysate 2 mean 155 ng/mL SD 7. Eleesys Folate RBC Test System including Folate RBC Assay Rack Pack the Folate RBC CalSet and the Folate RBC CalCheck MY1221 510 k Summary Introduction According to the requirements of 21 CFR 807. 2 CV...

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