VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67— 510(k) K053520

Name: FDA 510(k) clearance K053520
Creator: U.S. Food and Drug Administration
Published: 2006-04-11

Substantially Equivalent

Tripath Imaging, Inc.

FDA 510(k) clearance K053520 for VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67, Substantially Equivalent on 2006-04-11. Applicant: Tripath Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Tripath Imaging, Inc.
Product code: Code NQN
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2005-12-19
Decision date: 2006-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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