| Device Classification Name |
Supplement, Culture Media
|
| 510(k) Number |
K760589 |
| Device Name |
VCA INHIBITOR |
| Applicant |
| Bd Becton Dickinson Vacutainer Systems Preanalytic |
| 1875 Eye St. NW Suite 625 |
|
Washington,
DC
20006
|
|
| Correspondent |
| Bd Becton Dickinson Vacutainer Systems Preanalytic |
| 1875 Eye St. NW Suite 625 |
|
Washington,
DC
20006
|
|
| Regulation Number | 866.2450 |
| Classification Product Code |
|
| Date Received | 09/03/1976 |
| Decision Date | 10/07/1976 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Microbiology
|
| 510k Review Panel |
Microbiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|