CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION

CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION is an FDA 510(k)-cleared medical device (K991605) 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 July 8, 1999. Regulation: 8.