ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM

ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K141867) 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 March 2, 2015. Regulation: 8.