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Becton Dickinson Immunocytometry Systems
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BD FACS 7-COLOR SETUP BEADS is an FDA 510(k)-cleared medical device (K040026) 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 September 9, 2004. Regulation: 8.