HYDRASHIFT 2/4 daratumumab

HYDRASHIFT 2/4 daratumumab is an FDA 510(k)-cleared medical device (K190851) manufactured by Sebia. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 1, 2019. Regulation: 8.