CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM


Device Classification Name

system, immunomagnetic, circulating cancer cell, enumeration

510(k) Number DEN040001
Device Name CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM
Applicant
ADVANCED DIAGNOSTIC SYSTEMS
1001 us hwy 202
raritan, 
NJ 
08869 -0606

Applicant Contact debra j rasmussen
Correspondent
ADVANCED DIAGNOSTIC SYSTEMS
1001 us hwy 202
raritan, 
NJ 
08869 -0606

Correspodent Contact debra j rasmussen
Regulation Number 866.6020
Classification Product Code
NQI  
Date Received 01/02/2004
Decision Date 01/21/2004
Decision

an

(AN)

Regulation Medical Specialty

Immunology

510k Review Panel

Pathology

Type Post-NSE

Reviewed by Third Party No

Combination Product

No