The following data is part of a premarket notification filed by Abbott Laboratories Inc with the FDA for Axsym Cyclosporine.
| Device ID | K040761 |
| 510k Number | K040761 |
| Device Name: | AXSYM CYCLOSPORINE |
| Classification | Cyclosporine |
| Applicant | ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD Abbott Park, IL 60064 |
| Contact | Grace Lemieux |
| Correspondent | Grace Lemieux ABBOTT LABORATORIES INC 100 ABBOTT PARK ROAD Abbott Park, IL 60064 |
| Product Code | MKW |
| CFR Regulation Number | 862.1235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-25 |
| Decision Date | 2004-04-30 |
| Summary: | summary |