The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Amicus Separator System.
| Device ID | K192150 |
| 510k Number | K192150 |
| Device Name: | AMICUS Separator System |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | Fresenius Kabi AG Bad Homburg, DE 61346 |
| Contact | Aunica Jones |
| Correspondent | Aunica Jones Fenwal, Inc. Three Corporate Drive Lake Zurich, IL 60047 |
| Product Code | LKN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-09 |
| Decision Date | 2019-11-13 |