ACCU-CHEK AVIVA EXPERT SYSTEM

ACCU-CHEK AVIVA EXPERT SYSTEM is an FDA 510(k)-cleared medical device (K142089) manufactured by Roche Diagnostics Corporation. 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 December 16, 2014. Regulation: 8.