SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I

SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I is an FDA 510(k)-cleared medical device (K021241) manufactured by Sysmex Corporation of America. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 24, 2002. Regulation: 8.