DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III

DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III is an FDA 510(k)-cleared medical device (K903566) manufactured by Baxter Healthcare Corp. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 23, 1990. Regulation: 8.