
Toa Medical Electronics USA, Inc.
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SYSMEX CC-150 is an FDA 510(k)-cleared medical device (K830506) manufactured by Toa Medical Electronics USA, 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 May 8, 1983. Regulation: 8.