
Beckman Coulter, Inc.
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5C-ES CELL CONTROL, MODELS 7547191, 7547192 is an FDA 510(k)-cleared medical device (K010066) 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 February 6, 2001. Regulation: 8.