CELL-DYN 3000 CONTROL

CELL-DYN 3000 CONTROL is an FDA 510(k)-cleared medical device (K902391) manufactured by Unipath , Ltd.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 1990. Regulation: 8.