
Endocrine-Metabolic Center
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RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE is an FDA 510(k)-cleared medical device (K810351) manufactured by Endocrine-Metabolic Center. 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 February 22, 1981. Regulation: 8.