ADVIA IMS CARBAMAZEPINE METHOD

ADVIA IMS CARBAMAZEPINE METHOD is an FDA 510(k)-cleared medical device (K042808) manufactured by Bayer Healthcare, LLC. 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 February 7, 2005. Regulation: 8.