
Biotrol, USA, Inc.
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BIOTROL BICARBONATE (CO2) UV HP) is an FDA 510(k)-cleared medical device (K874941) manufactured by Biotrol, USA, Inc.. 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 4, 1988. Regulation: 8.