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510(k) K111872

Device
VIRTUOSO SYSTEM FOR IHC P53 (DO-7)
Applicant
Ventana Medical Systems, Inc.
510(k) number
K111872
Product code
NQN
Decision
Substantially Equivalent (SESE)
Decision date
2012-04-19
Date received
2011-07-01
Regulation
864.1860
Classification name
Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
TROY QUANDER
Address
1910 E. Innovation Park Dr. Tucson AZ US 85755 85755

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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