DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE

DRI-SATE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSATE is an FDA 510(k)-cleared medical device (K022500) manufactured by Rockwell Medical Technologies, 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 December 22, 2002. Regulation: 8.