EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO

EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO is an FDA 510(k)-cleared medical device (K820440) manufactured by Syva 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 March 14, 1982. Regulation: 8.