CELLTRACKS AUTOPREP SYSTEM


Device Classification Name

system, immunomagnetic, circulating cancer cell, enumeration

510(k) Number K110406
Device Name CELLTRACKS AUTOPREP SYSTEM
Applicant
VERIDEX, LLC
1001 us highway 202 north
raritan, 
NJ 
08869 -0606

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

Correspodent Contact jessica shelffo
Regulation Number 866.6020
Classification Product Code
NQI  
Date Received 02/14/2011
Decision Date 01/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Pathology

statement

statement

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls