
Coulter Corp.
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CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON is an FDA 510(k)-cleared medical device (K926124) 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 July 5, 1993. Regulation: 8.