
Dakocytomation California, Inc.
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CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES is an FDA 510(k)-cleared medical device (K060423) manufactured by Dakocytomation California, 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 August 14, 2006. Regulation: 8.