ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER

ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER is an FDA 510(k)-cleared medical device (K780946) manufactured by Hycel, Inc.. 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 26, 1978. Regulation: 8.