
Sysmex America, Inc.
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XW-100 Automated Hematology Analyzer for CLIA Waived Use is an FDA 510(k)-cleared medical device (K172604) 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 November 5, 2017. Regulation: 8.