EMIT AED ASSAYS 3500 COMPUTER DIRECTED

EMIT AED ASSAYS 3500 COMPUTER DIRECTED is an FDA 510(k)-cleared medical device (K790255) 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 1, 1979. Regulation: 8.