STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III

STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III is an FDA 510(k)-cleared medical device (K860906) manufactured by American Dade. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 28, 1986. Regulation: 8.