| Device Classification Name |
gram-positive bacteria and their resistance markers
|
|---|
| 510(K) Number |
K113450 |
|---|
| Device Name |
VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) |
|---|
| Applicant |
| NANOSPHERE, INC |
| 4088 commercial avenue |
|
northbrook,
IL
60062
|
|
| Contact |
mark del vecchio |
| Regulation Number | 866.3365
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 11/21/2011 |
|---|
| Decision Date | 06/26/2012 |
|---|
| Decision |
de novo petitions granted (AN) |
|---|
| Classification Advisory Committee |
Microbiology
|
|---|
| Review Advisory Committee |
Microbiology
|
|---|
| FOI Item |
Approval Letter
|
| FDA Review |
Decision Summary
|
|---|
| Type |
De Novo Petitions Granted
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
