R&D CBC-XE HEMATOLOGY CONTROL

R&D CBC-XE HEMATOLOGY CONTROL is an FDA 510(k)-cleared medical device (K042094) manufactured by R&D Systems, 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 August 31, 2004. Regulation: 8.