ROCHE ONLINE TDM VALPROIC ACID

ROCHE ONLINE TDM VALPROIC ACID is an FDA 510(k)-cleared medical device (K032049) 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 August 21, 2003. Regulation: 8.