GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE

GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE is an FDA 510(k)-cleared medical device (K112356) 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 September 18, 2011. Regulation: 8.