THYROSCREEN TM T4 DIAGNOSTIC KIT

THYROSCREEN TM T4 DIAGNOSTIC KIT is an FDA 510(k)-cleared medical device (K770474) manufactured by Abbott Laboratories. 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 April 27, 1977. Regulation: 8.