SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-

SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- is an FDA 510(k)-cleared medical device (K850239) 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 March 31, 1985. Regulation: 8.