Device Classification Name |
sirolimus test system
|
De Novo Number |
DEN040008 |
510(K) Number |
K034069
|
Device Name |
CEDIA SIROLIMUS ASSAY |
Requester |
microgenics corp. |
46360 fremont blvd. |
fremont,
CA
94538
|
|
Contact |
david casal |
|
Regulation Number | 862.3840
|
Classification Product Code |
|
Date Received | 06/17/2004 |
Decision Date | 07/28/2004 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Toxicology
|
Review Advisory Committee |
Clinical Chemistry
|
Classification Order |
Classification Order
|
Type |
Post-NSE
|
|
|