DIACLEAR ULTRAFILTER

DIACLEAR ULTRAFILTER is an FDA 510(k)-cleared medical device (K003957) 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 October 31, 2001. Regulation: 8.