BICARBOLYTE HEMO-DIAL

BICARBOLYTE HEMO-DIAL is an FDA 510(k)-cleared medical device (K833896) manufactured by Edlaw Pharmaceuticals, Inc.. 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 January 2, 1984. Regulation: 8.