BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE

BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE is an FDA 510(k)-cleared medical device (K895199) 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 December 12, 1989. Regulation: 8.