HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY is an FDA 510(k)-cleared medical device (K130685) manufactured by Hitachi Chemical Diagnostics, Inc.. 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 8, 2013. Regulation: 8.