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Abbott Laboratories
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CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE is an FDA 510(k)-cleared medical device (K012934) manufactured by Abbott Laboratories. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 27, 2001. Regulation: 8.