E-Z CHECK OZONE TEST STRIPS

E-Z CHECK OZONE TEST STRIPS is an FDA 510(k)-cleared medical device (K132344) manufactured by Reprocessing Products Corporation (Rpc). This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 24, 2014. Regulation: 8.