SYVA EMIT II PROPOXYPHENE ASSAY

SYVA EMIT II PROPOXYPHENE ASSAY is an FDA 510(k)-cleared medical device (K923873) 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 November 1, 1992. Regulation: 8.