
Abbott Diagnostics
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CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER is an FDA 510(k)-cleared medical device (K890491) 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 April 17, 1989. Regulation: 8.