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Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
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BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C is an FDA 510(k)-cleared medical device (K093394) 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 April 7, 2010. Regulation: 8.