The following data is part of a premarket notification filed by Tripath Imaging with the FDA for Ventana Image Analysis System - Pathway Her2 (4b5).
Device ID | K061613 |
510k Number | K061613 |
Device Name: | VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5) |
Classification | Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
Applicant | TRIPATH IMAGING 4025 STIRRUP CREEK DR. SUITE 400 Durham, NC 27703 |
Contact | Bryan J Tucker |
Correspondent | Bryan J Tucker TRIPATH IMAGING 4025 STIRRUP CREEK DR. SUITE 400 Durham, NC 27703 |
Product Code | NQN |
CFR Regulation Number | 864.1860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-09 |
Decision Date | 2007-01-10 |