CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY

CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY is an FDA 510(k)-cleared medical device (K964765) manufactured by Chiron 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 February 13, 1997. Regulation: 8.