VIRTUOSO SYSTEM FOR IHC PR (IE2)— 510(k) K111869

Name: FDA 510(k) clearance K111869
Creator: U.S. Food and Drug Administration
Published: 2012-03-05

Substantially Equivalent

Ventana Medical Systems, Inc.

FDA 510(k) clearance K111869 for VIRTUOSO SYSTEM FOR IHC PR (IE2), Substantially Equivalent on 2012-03-05. Applicant: Ventana Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Ventana Medical Systems, Inc.
Product code: Code NQN
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2011-07-01
Decision date: 2012-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

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