ACS DIGOXIN IMMUNOASSAY

ACS DIGOXIN IMMUNOASSAY is an FDA 510(k)-cleared medical device (K931213) manufactured by Ciba Corning Diagnostics Corp.. 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 June 6, 1993. Regulation: 8.