MICROZYME T3 ENZYME IMMUNOASSAY KIT

MICROZYME T3 ENZYME IMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K904820) manufactured by Immunotech Corp.. 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 December 17, 1990. Regulation: 8.