The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Cell-dyn Sapphire System.
| Device ID | K051215 |
| 510k Number | K051215 |
| Device Name: | CELL-DYN SAPPHIRE SYSTEM |
| Classification | Counter, Differential Cell |
| Applicant | ABBOTT LABORATORIES 5440 PATRICK HENRY DR. Santa Clara, CA 95054 |
| Contact | Michelle Roeding |
| Correspondent | Michelle Roeding ABBOTT LABORATORIES 5440 PATRICK HENRY DR. Santa Clara, CA 95054 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-12 |
| Decision Date | 2005-07-21 |
| Summary: | summary |