
Cronus
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I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT is an FDA 510(k)-cleared medical device (K871193) manufactured by Cronus. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 14, 1987. Regulation: 8.