SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY

SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY is an FDA 510(k)-cleared medical device (K820187) 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 February 11, 1982. Regulation: 8.