Device Classification Name |
cardiac allograft gene expression profiling test system
|
De Novo Number |
DEN080007 |
510(K) Number |
K073482
|
Device Name |
ALLOMAP MOLECULAR EXPRESSION TESTING |
Requester |
XDX |
3260 bayshore boulevard |
brisbane,
CA
94005
|
|
Contact |
rose romeo |
|
Regulation Number | 862.1163
|
Classification Product Code |
|
Date Received | 08/15/2008 |
Decision Date | 08/26/2008 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Clinical Chemistry
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|