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Ventana Medical Systems, Inc.
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VIRTUOSO SYSTEM FOR IHC HER2 (4B5) is an FDA 510(k)-cleared medical device (K121516) manufactured by Ventana Medical Systems, 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 September 25, 2013. Regulation: 8.