
Coulter Electronics, Inc.
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COULTER RETIC-C CELL CONTROL is an FDA 510(k)-cleared medical device (K930119) manufactured by Coulter Electronics, Inc.. 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 4, 1993. Regulation: 8.