ELITECH CLINICAL SYSTEMS CK NAC SL

ELITECH CLINICAL SYSTEMS CK NAC SL is an FDA 510(k)-cleared medical device (K122083) manufactured by Elitechgroup. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 21, 2012. Regulation: 8.