EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS

EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS is an FDA 510(k)-cleared medical device (K903152) 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 August 16, 1990. Regulation: 8.