ACS PHENYTOIN ASSAY

ACS PHENYTOIN ASSAY is an FDA 510(k)-cleared medical device (K955873) 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 March 10, 1996. Regulation: 8.