Medical Device Manufacturer · US , Burlington , NC

Tripath Imaging, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2005

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Tripath Imaging, Inc. Pathology ✕

4 devices

1-4 of 4

Cleared Sep 29, 2006

VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS

Pathology · 42d

Cleared Apr 11, 2006

VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67

Pathology · 113d

Cleared Aug 16, 2005

VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU

Pathology · 91d

Cleared May 06, 2005

VENTANA IMAGE ANALYSIS SYSTEM

Pathology · 123d