STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY

STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY is an FDA 510(k)-cleared medical device (K862067) manufactured by American Dade. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 1986. Regulation: 8.