The following data is part of a premarket notification filed by Fresenius Kabi Usa Llc. with the FDA for Automated Blood Cell Separators.
| Device ID | BK150357 |
| 510k Number | BK150357 |
| Device Name: | Automated Blood Cell Separators |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | Fresenius Kabi USA LLC. three Corporate Drive Lake Zurich, IL 60047 |
| 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 | 2015-12-17 |
| Decision Date | 2016-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14086000101384 | BK150357 | 0 |
| 14086000101377 | BK150357 | 0 |
| 10810020440161 | BK150357 | 0 |
| 00810020440140 | BK150357 | 0 |