BAKER DIAG. ULTRARATE CO2 REAGENT KIT

BAKER DIAG. ULTRARATE CO2 REAGENT KIT is an FDA 510(k)-cleared medical device (K802035) manufactured by J.T. Baker Chemical Co.. 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 25, 1980. Regulation: 8.