Device Classification Name |
gram-positive bacteria and their resistance markers
|
De Novo Number |
DEN120014 |
510(K) Number |
K113450
|
Device Name |
VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) |
Requester |
nanosphere, inc |
4088 commercial avenue |
northbrook,
IL
60062
|
|
Contact |
mark del vecchio |
|
Regulation Number | 866.3365
|
Classification Product Code |
|
Date Received | 06/15/2012 |
Decision Date | 06/26/2012 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Microbiology
|
Review Advisory Committee |
Microbiology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Post-NSE
|
|
|