WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2

WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 is an FDA 510(k)-cleared medical device (K941876) manufactured by More Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 27, 1994. Regulation: 8.