DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL

DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL is an FDA 510(k)-cleared medical device (K912455) 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 August 11, 1991. Regulation: 8.