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Sysmex America, Inc.
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SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L) is an FDA 510(k)-cleared medical device (K040073) manufactured by Sysmex America, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 17, 2004. Regulation: 8.