
Becton Dickinson Immunocytometry Systems
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TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS is an FDA 510(k)-cleared medical device (K970836) 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 25, 1997. Regulation: 8.