CO2 CALIBRATOR/DILUENT

CO2 CALIBRATOR/DILUENT is an FDA 510(k)-cleared medical device (K033643) manufactured by Bayer Healthcare, Diagnostics Division. 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 7, 2004. Regulation: 8.