
Sysmex America, Inc.
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Sysmex XN-L Automated Hematology Analyzer is an FDA 510(k)-cleared medical device (K160538) 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 December 21, 2016. Regulation: 8.