| Device Classification Name |
antigens, all groups, streptococcus spp.
|
|---|
| 510(K) Number |
K122718 |
|---|
| Device Name |
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP |
|---|
| Applicant |
| BECTON, DICKINSON AND COMPANY |
| 10865 road to the cure, |
| suite 200 |
|
san diego,
CA
92121
|
|
| Contact |
gregory p payne |
| Regulation Number | 866.3740
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 09/05/2012 |
|---|
| Decision Date | 02/06/2013 |
|---|
| Decision |
substantially equivalent - CLIA submission (CS) |
|---|
| Classification Advisory Committee |
Microbiology
|
|---|
| Review Advisory Committee |
Microbiology
|
|---|
| summary |
summary
|
| FDA Review |
Decision Summary
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
