RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS

RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS is an FDA 510(k)-cleared medical device (K081478) 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 October 5, 2008. Regulation: 8.