SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500

SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500 is an FDA 510(k)-cleared medical device (K981950) manufactured by Sysmex Corp.. 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 2, 1998. Regulation: 8.