HemoCare Bicarbonate Concentrate Set (BCS)

HemoCare Bicarbonate Concentrate Set (BCS) is an FDA 510(k)-cleared medical device (K240920) manufactured by Deka Research and Development. 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 July 11, 2024. Regulation: 8.