
Tripath Imaging, Inc.
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VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67 is an FDA 510(k)-cleared medical device (K053520) manufactured by Tripath Imaging, 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 April 10, 2006. Regulation: 8.