BC-3200 AUTO HEMATOLOGY ANALYZER

BC-3200 AUTO HEMATOLOGY ANALYZER is an FDA 510(k)-cleared medical device (K063407) manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 10, 2007. Regulation: 8.