ELITTECH CLINICAL SYSTEMS ALP IFCC SL

ELITTECH CLINICAL SYSTEMS ALP IFCC SL is an FDA 510(k)-cleared medical device (K113269) 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 December 28, 2011. Regulation: 8.