CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE

CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE is an FDA 510(k)-cleared medical device (K940089) 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 March 21, 1994. Regulation: 8.