
Sysmex America, Inc.
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Sysmex XR-Series (XR-20) Automated Hematology Analyzer is an FDA 510(k)-cleared medical device (K251371) 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 June 24, 2025. Regulation: 8.