MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT— 510(k) K052191

Name: FDA 510(k) clearance K052191
Creator: U.S. Food and Drug Administration
Published: 2005-10-27

Substantially Equivalent

Veridex, LLC

FDA 510(k) clearance K052191 for MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT, Substantially Equivalent on 2005-10-27. Applicant: Veridex, LLC. Device class: 2.

Clearance details

Applicant: Veridex, LLC
Product code: Code NQI
Device class: Class 2
Regulation: 21 CFR 866.6020
Advisory panel: Immunology
Date received: 2005-08-11
Decision date: 2005-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

Download summary PDF View on FDA.gov ↗

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