Device Classification Name |
norovirus serological reagent
|
De Novo Number |
DEN110001 |
510(K) Number |
K093295
|
Device Name |
RIDASCREEN NOROVIRUS 3RD GENERATION EIA |
Requester |
R-Biopharm AG |
150 cherry lane rd |
east stroudsburg,
PA
18301
|
|
Contact |
gary lehnus |
|
Regulation Number | 866.3395
|
Classification Product Code |
|
Date Received | 02/16/2011 |
Decision Date | 02/23/2011 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Microbiology
|
Review Advisory Committee |
Microbiology
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|