
Beckman Coulter, Inc.
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COULTER 4C-EX 300 CELL CONTROL is an FDA 510(k)-cleared medical device (K100607) manufactured by Beckman Coulter, Inc.. 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 17, 2010. Regulation: 8.