BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS

BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS is an FDA 510(k)-cleared medical device (K880102) manufactured by Baxter Healthcare 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 May 25, 1988. Regulation: 8.