Device Classification Name |
system, immunomagnetic, circulating cancer cell, enumeration
|
De Novo Number |
DEN040001 |
510(K) Number |
K031588
|
Device Name |
CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM |
Requester |
advanced diagnostic systems |
1001 us hwy 202 |
raritan,
NJ
08869 -0606
|
|
Contact |
debra j rasmussen |
|
Regulation Number | 866.6020
|
Classification Product Code |
|
Date Received | 01/02/2004 |
Decision Date | 01/21/2004 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Immunology
|
Review Advisory Committee |
Pathology
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|