CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001


Device Classification Name

system, immunomagnetic, circulating cancer cell, enumeration

510(k) Number K103502
Device Name CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
Applicant
VERIDEX, LLC
1001 us highway 202 north
raritan, 
NJ 
08869 -0606

Applicant Contact sarah mcmanus
Correspondent
VERIDEX, LLC
1001 us highway 202 north
raritan, 
NJ 
08869 -0606

Correspodent Contact sarah mcmanus
Regulation Number 866.6020
Classification Product Code
NQI  
Date Received 11/29/2010
Decision Date 12/21/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Pathology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No