STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY

STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K862428) 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 August 18, 1986. Regulation: 8.