ABBOTT CARBAMAZEPINE ASSAY

ABBOTT CARBAMAZEPINE ASSAY is an FDA 510(k)-cleared medical device (K123518) manufactured by Microgenics Corporation. 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 June 4, 2013. Regulation: 8.