| Device Classification Name |
cyclosporine |
|||
|---|---|---|---|---|
| 510(k) Number | K080751 | |||
| Device Name | ARCHITECT CYCLOSPORINE | |||
| Applicant |
|
|||
| Applicant Contact | stacey moll | |||
| Correspondent |
|
|||
| Correspodent Contact | stacey moll | |||
| Regulation Number | 862.1235 | |||
| Classification Product Code |
|
|||
| Subsequent Product Code |
|
|||
| Date Received | 03/18/2008 | |||
| Decision Date | 09/11/2008 | |||
| Decision |
substantially equivalent (SESE) |
|||
| Regulation Medical Specialty |
Clinical Chemistry |
|||
| 510k Review Panel |
Toxicology |
|||
| summary |
summary |
|||
| FDA Review | Decision Summary | |||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |
|||
| Recalls | CDRH Recalls |