
Sysmex Corp.
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SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER is an FDA 510(k)-cleared medical device (K992875) manufactured by Sysmex Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 8, 1999. Regulation: 8.