
Roche Diagnostics
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ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K101299) 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 September 20, 2011. Regulation: 8.