MONOCLONAL ANTIBODY ANTI-CD19

MONOCLONAL ANTIBODY ANTI-CD19 is an FDA 510(k)-cleared medical device (K901186) manufactured by Sigma Chemical Co.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 30, 1991. Regulation: 8.