ETHANOL CONTROLS LOW & HIGH E5133/E5258

ETHANOL CONTROLS LOW & HIGH E5133/E5258 is an FDA 510(k)-cleared medical device (K843872) manufactured by Sigma Chemical Co.. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 30, 1984. Regulation: 8.