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FDA 510(k), K121516, VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
FDA 510(k), K121516, VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
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510(K) Number: K121516
Device Name: VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
Manufacturer: VENTANA MEDICAL SYSTEMS, INC.
Device Classification Name: microscope, automated, image analysis, immunohistochemistry,operator intervention,nuclear intensity & percent positivity
Regulation Number: 864.1860
Classification Product Code: NQN
Date Received: 05/22/2012
Decision Date: 09/26/2013
Regulation Medical Specialty: Hematology
Device Name: VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
Manufacturer: VENTANA MEDICAL SYSTEMS, INC.
Device Classification Name: microscope, automated, image analysis, immunohistochemistry,operator intervention,nuclear intensity & percent positivity
Regulation Number: 864.1860
Classification Product Code: NQN
Date Received: 05/22/2012
Decision Date: 09/26/2013
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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