ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM

ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K121679) 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 October 10, 2012. Regulation: 8.