STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III

STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III is an FDA 510(k)-cleared medical device (K874757) manufactured by Baxter Healthcare Corp. This device is classified under the Clinical Toxicology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 1, 1988. Regulation: 8.