TDX(R) BARBITURATES II ASSAY

TDX(R) BARBITURATES II ASSAY is an FDA 510(k)-cleared medical device (K896550) manufactured by Abbott Laboratories. 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 December 18, 1989. Regulation: 8.