KRONUS OPTIQUANT THYROGLOBULIN KIT

KRONUS OPTIQUANT THYROGLOBULIN KIT is an FDA 510(k)-cleared medical device (K991720) manufactured by Unchanged. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 8, 1999. Regulation: 8.