ADVANCE EMIT CAD PROCAINAMIDE ASSAY

ADVANCE EMIT CAD PROCAINAMIDE ASSAY is an FDA 510(k)-cleared medical device (K823128) 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 28, 1982. Regulation: 8.