VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)— 510(k) K111543

Name: FDA 510(k) clearance K111543
Creator: U.S. Food and Drug Administration
Published: 2011-10-12

Substantially Equivalent

Ventana Medical Systems, Inc.

FDA 510(k) clearance K111543 for VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5), Substantially Equivalent on 2011-10-12. Applicant: Ventana Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Ventana Medical Systems, Inc.
Product code: Code NOT
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2011-06-02
Decision date: 2011-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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