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510(k) K122143

VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER by Ventana Medical Systems, Inc. — Product Code NQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2013
Date Received
July 19, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
Device Class
Class II
Regulation Number
864.1860
Review Panel
PA
Submission Type

Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.

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  • K073677 — SCANSCOPE XT SYSTEM (August 1, 2008)
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