PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT

PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT is an FDA 510(k)-cleared medical device (K912231) manufactured by Intl. Immunoassay Laboratories, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 7, 1991. Regulation: 8.