FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3

FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 is an FDA 510(k)-cleared medical device (K092645) 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 September 4, 2009. Regulation: 8.