ELECSYS RUBELLA IGGA CALCHECK 5

ELECSYS RUBELLA IGGA CALCHECK 5 is an FDA 510(k)-cleared medical device (K092585) manufactured by Roche Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 29, 2009. Regulation: 8.