DIGOXIN RADIOIMMUNOASSAY

DIGOXIN RADIOIMMUNOASSAY is an FDA 510(k)-cleared medical device (K820274) manufactured by American Diagnostic Corp.. 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 February 22, 1982. Regulation: 8.