About This 510(k) Submission
K180615 is an FDA 510(k) clearance for the AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter, a Separator, Automated, Blood Cell And Plasma, Therapeutic, submitted by Fresenius Kabi USA,Llc (Lake Zurich, US). The FDA issued a Cleared decision on December 4, 2018, 271 days after receiving the submission on March 8, 2018. This device falls under the Gastroenterology & Urology review panel.