FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA

FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA is an FDA 510(k)-cleared medical device (K123612) manufactured by Fujirebio Diagnostics,Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 16, 2013. Regulation: 8.