HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES

HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES is an FDA 510(k)-cleared medical device (K860297) manufactured by Renal Hygienics. 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 3, 1986. Regulation: 8.