ROCHE DIAGNOSTICS OMNI S ANALYZER

ROCHE DIAGNOSTICS OMNI S ANALYZER is an FDA 510(k)-cleared medical device (K032311) manufactured by Roche Diagnostics 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 October 16, 2003. Regulation: 8.