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C/o MR. MICHAEL LOCKE DIRECTOR OF REGULATORY AFFAIRS 1100 THE AMERICAN ROAD MORRIS PLAINS NJ 07950 Re K141827 Trade/Device Name EUROIMMUN IFA 40 HEp-20-10 EUROPattern EUROPattern Microscope and Software Regulation Number 21 CFR 866. Fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also please note the regulation entitled sMisbranding by reference to premarket notifications 21CFR Part 807. 5100 Regulatory Class II Product Code DHN PIV Dated March 17 2015 Received March 18 2015 Dear...

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