QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM

QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM is an FDA 510(k)-cleared medical device (K023058) manufactured by Seradyn. 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 October 23, 2002. Regulation: 8.