
Abbott Diagnostics
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CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY is an FDA 510(k)-cleared medical device (K852371) manufactured by Abbott Diagnostics. 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 16, 1985. Regulation: 8.