VENTANA IMAGE ANALYSIS SYSTEM— 510(k) K050012

Name: FDA 510(k) clearance K050012
Creator: U.S. Food and Drug Administration
Published: 2005-05-06

Substantially Equivalent

Tripath Imaging, Inc.

FDA 510(k) clearance K050012 for VENTANA IMAGE ANALYSIS SYSTEM, Substantially Equivalent on 2005-05-06. 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: 2005-01-03
Decision date: 2005-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, NC, US

Download summary PDF View on FDA.gov ↗

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