
Toa Medical Electronics USA, Inc.
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SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM is an FDA 510(k)-cleared medical device (K882767) manufactured by Toa Medical Electronics USA, Inc.. This device is classified under the Hematology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 17, 1988. Regulation: 8.