EZ-BEAD TSH ENZYME IMMUNOASSAY KIT

EZ-BEAD TSH ENZYME IMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K903725) 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 October 25, 1990. Regulation: 8.