CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY

CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY is an FDA 510(k)-cleared medical device (K903665) 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 October 3, 1990. Regulation: 8.