
Sequoia Turner Corp.
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ABBOTT CELL-DYN 3500R SYSTEM is an FDA 510(k)-cleared medical device (K960427) manufactured by Sequoia Turner Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 1, 1996. Regulation: 8.