SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL

SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL is an FDA 510(k)-cleared medical device (K994005) 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 January 19, 2000. Regulation: 8.