IMMU-TRACE T3 UPTAKE (T3U) REAGENTS

IMMU-TRACE T3 UPTAKE (T3U) REAGENTS is an FDA 510(k)-cleared medical device (K803044) manufactured by American Dade. 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 January 1, 1981. Regulation: 8.