| 510(k) Number |
K770731 |
| Device Name |
EAGENT SYSTEM, CORTISOL, ARIA |
| 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
|
|
| Date Received | 04/20/1977 |
| Decision Date | 06/24/1977 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Immunology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|