MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT

System, Immunomagnetic, Circulating Cancer Cell, Enumeration

VERIDEX, LLC

The following data is part of a premarket notification filed by Veridex, Llc with the FDA for Modification To Cellsearch Circulating Tumor Cell Kit.

Pre-market Notification Details

Device IDK052191
510k NumberK052191
Device Name:MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT
ClassificationSystem, Immunomagnetic, Circulating Cancer Cell, Enumeration
Applicant VERIDEX, LLC 1001 US HIGHWAY 202 NORTH Raritan,  NJ  08869 -0606
ContactDebra J Rasmussen
CorrespondentDebra J Rasmussen
VERIDEX, LLC 1001 US HIGHWAY 202 NORTH Raritan,  NJ  08869 -0606
Product CodeNQI  
CFR Regulation Number866.6020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-11
Decision Date2005-10-27

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