TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES

TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES is an FDA 510(k)-cleared medical device (K902243) manufactured by Technicon Instruments Corp.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 4, 1990. Regulation: 8.