
Bayer Healthcare, Diagnostics Division
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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.