REAGENTS FOR ORION 1020, AND RELATED ANALYZERS

REAGENTS FOR ORION 1020, AND RELATED ANALYZERS is an FDA 510(k)-cleared medical device (K935018) 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 January 17, 1994. Regulation: 8.