ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS

ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS is an FDA 510(k)-cleared medical device (K972004) manufactured by Alko Diagnostic Corp.. 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 15, 1997. Regulation: 8.