EMIT NORTRIPTYLINE ASSAY

EMIT NORTRIPTYLINE ASSAY is an FDA 510(k)-cleared medical device (K870823) 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 19, 1987. Regulation: 8.