OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER

OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER is an FDA 510(k)-cleared medical device (K981743) manufactured by Olympus America, 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 June 8, 1998. Regulation: 8.