CEDIA PHENYTOIN II ASSAY

CEDIA PHENYTOIN II ASSAY is an FDA 510(k)-cleared medical device (K963840) manufactured by Boehringer Mannheim 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 November 19, 1996. Regulation: 8.