EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE

EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE is an FDA 510(k)-cleared medical device (K910527) 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 13, 1991. Regulation: 8.