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Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CFR Part 807. 1295 Regulatory Class II Product Code CGN JIT JJX Dated September 27 2016 Received October 04 2016 Dear Dr. D DIRECTOR TECHNICAL OPERATIONS 12889 GREGG COURT POWAY CA 92130 November 4 2016 Re K161646 Trade/Device Name Diazyme Folate Assay Diazyme Folate Calibrator Set Regulation Number 21 CFR 862. Abhijit Datta electronic...
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