
American Dade
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STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. is an FDA 510(k)-cleared medical device (K870158) manufactured by American Dade. 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 March 18, 1987. Regulation: 8.