SIMULTEST CD3/ANTI-HLA-DR

SIMULTEST CD3/ANTI-HLA-DR is an FDA 510(k)-cleared medical device (K924587) manufactured by Becton Dickinson Immunocytometry Systems. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 4, 1993. Regulation: 8.