ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR

ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR is an FDA 510(k)-cleared medical device (K952282) manufactured by Roche Diagnostic Systems, 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 September 14, 1995. Regulation: 8.