
Coulter Immunology
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CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI is an FDA 510(k)-cleared medical device (K895917) manufactured by Coulter Immunology. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 28, 1989. Regulation: 8.