VIRTUOSO SYSTEM FOR IHC HER2 (4B5)— 510(k) K121516

Name: FDA 510(k) clearance K121516
Creator: U.S. Food and Drug Administration
Published: 2013-09-26

Substantially Equivalent

Ventana Medical Systems, Inc.

FDA 510(k) clearance K121516 for VIRTUOSO SYSTEM FOR IHC HER2 (4B5), Substantially Equivalent on 2013-09-26. 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: 2012-05-22
Decision date: 2013-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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