ROCHE ONLINE TDM PHENYTOIN

ROCHE ONLINE TDM PHENYTOIN is an FDA 510(k)-cleared medical device (K030428) manufactured by Roche 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 April 27, 2003. Regulation: 8.