VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)— 510(k) K061613

Name: FDA 510(k) clearance K061613
Creator: U.S. Food and Drug Administration
Published: 2007-01-10

Substantially Equivalent

Tripath Imaging

FDA 510(k) clearance K061613 for VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5), Substantially Equivalent on 2007-01-10. Applicant: Tripath Imaging. Device class: 2.

Clearance details

Applicant: Tripath Imaging
Product code: Code NQN
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2006-06-09
Decision date: 2007-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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