COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B

COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B is an FDA 510(k)-cleared medical device (K111188) manufactured by Roche Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 13, 2012. Regulation: 8.