The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Cell-dyn Emerald 22 Al System.
| Device ID | K190294 |
| 510k Number | K190294 |
| Device Name: | CELL-DYN Emerald 22 AL System |
| Classification | Counter, Differential Cell |
| Applicant | Abbott Laboratories 4551 Great America Pkwy Santa Clara, CA 95054 |
| Contact | Madhu Gill |
| Correspondent | Madhu Gill Abbott Laboratories 4551 Great America Pkwy Santa Clara, CA 95054 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-11 |
| Decision Date | 2019-03-15 |