IL SYSTEM 810, ACL AND THE REAGENT SETS

IL SYSTEM 810, ACL AND THE REAGENT SETS is an FDA 510(k)-cleared medical device (K862301) manufactured by Instrumentation Laboratory CO. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 2, 1986. Regulation: 8.