Device Classification Name |
assay, endotoxin activity, chemiluminescent
|
De Novo Number |
DEN030002 |
510(K) Number |
K021885
|
Device Name |
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE |
Requester |
spectral diagnostics, inc. |
16809 briardale rd. |
rockville,
MD
20855
|
|
Contact |
tom tsakeris |
|
Regulation Number | 866.3210
|
Classification Product Code |
|
Date Received | 04/14/2003 |
Decision Date | 06/16/2003 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Microbiology
|
Review Advisory Committee |
Microbiology
|
Classification Order |
Classification Order
|
Type |
Post-NSE
|
|
|