
Coulter Electronics, Inc.
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4C ABNORMAL LOW-HIGH (8 X 6 M1) is an FDA 510(k)-cleared medical device (K760682) 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 7, 1976. Regulation: 8.