The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Automated Blood Cell Separators.
| Device ID | BK160028 |
| 510k Number | BK160028 |
| Device Name: | Automated Blood Cell Separators |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | Fresenius Kabi AG three Corporate Dr Lake Zurich, IL 60047 US |
| Product Code | GKT |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-01 |
| Decision Date | 2016-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04086000101523 | BK160028 | 0 |
| 04086000101516 | BK160028 | 0 |
| 04086000101097 | BK160028 | 0 |
| 10810020441113 | BK160028 | 0 |