
Coulter Electronics, Inc.
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COULTER DIFF3 SYS. (COULTER #7400003) is an FDA 510(k)-cleared medical device (K791903) 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 October 29, 1979. Regulation: 8.