DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT

DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT is an FDA 510(k)-cleared medical device (K780475) manufactured by Burroughs Wellcome Co.. 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 April 23, 1978. Regulation: 8.