
Coulter Electronics, Inc.
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DART (R) ELECTROLYTE REAGENT SYSTEM is an FDA 510(k)-cleared medical device (K874185) manufactured by Coulter Electronics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 3, 1987. Regulation: 8.