
Becton Dickinson Monoclonal Center
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FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS is an FDA 510(k)-cleared medical device (K961623) manufactured by Becton Dickinson Monoclonal Center. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 6, 1996. Regulation: 8.