POWDERED BICARBONATE CONCENTRATE

POWDERED BICARBONATE CONCENTRATE is an FDA 510(k)-cleared medical device (K865078) manufactured by Bicarbolyte Corp.. 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 March 26, 1987. Regulation: 8.