EMIT 2000 DIGOXIN ASSAY

EMIT 2000 DIGOXIN ASSAY is an FDA 510(k)-cleared medical device (K943500) 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 14, 1994. Regulation: 8.