GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK

GLUCOSE METER-CHECK CONTROL SOLUTION FOR ROCHE ACCU-CHEK is an FDA 510(k)-cleared medical device (K081403) manufactured by Bionostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 24, 2008. Regulation: 8.