DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS

DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS is an FDA 510(k)-cleared medical device (K011368) manufactured by Gambro Renal Products. 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 August 1, 2001. Regulation: 8.