VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU— 510(k) K051282

Substantially Equivalent

Tripath Imaging, Inc.

FDA 510(k) clearance K051282 for VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU, Substantially Equivalent on 2005-08-16. Applicant: Tripath Imaging, Inc..

Clearance details

Applicant: Tripath Imaging, Inc.
Product code: Code NOT
Advisory panel: Hematology
Date received: 2005-05-17
Decision date: 2005-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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