
Coulter Corp.
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RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS is an FDA 510(k)-cleared medical device (K990327) manufactured by Coulter Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 25, 1999. Regulation: 8.