CHLORIDE/CARBON DIOXIDE RATE REAGENT

CHLORIDE/CARBON DIOXIDE RATE REAGENT is an FDA 510(k)-cleared medical device (K811701) manufactured by Chem-Elec, 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 June 30, 1981. Regulation: 8.