
Kronus
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KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT is an FDA 510(k)-cleared medical device (K915428) manufactured by Kronus. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 29, 1992. Regulation: 8.