EMIT-AAD THEOPHYLLINE ASSAY

EMIT-AAD THEOPHYLLINE ASSAY is an FDA 510(k)-cleared medical device (K813240) 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 December 2, 1981. Regulation: 8.