CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS

CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS is an FDA 510(k)-cleared medical device (K944606) manufactured by Beckman-Diagnostic Systems Group. 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 November 29, 1994. Regulation: 8.