STAT PROFILE CRITICAL CARE XPRESS ANALYZER

STAT PROFILE CRITICAL CARE XPRESS ANALYZER is an FDA 510(k)-cleared medical device (K022746) manufactured by Nova Biomedical 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 November 21, 2002. Regulation: 8.