
Fresenius Kabi AG
Free shipping on orders over $99 · 30-day returns
AMICUS Separator System is an FDA 510(k)-cleared medical device (K200530) manufactured by Fresenius Kabi AG. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 2020. Regulation: 8.