WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2

WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 is an FDA 510(k)-cleared medical device (K912826) manufactured by Cala Diagnostics. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 25, 1991. Regulation: 8.