
Abbott Laboratories
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CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY is an FDA 510(k)-cleared medical device (K010953) 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 June 5, 2001. Regulation: 8.