Automated Blood Cell Separators
Separator, Automated, Blood Cell, Diagnostic
Fresenius Kabi USA LLC.
The following data is part of a premarket notification filed by Fresenius Kabi Usa Llc. with the FDA for Automated Blood Cell Separators.
Pre-market Notification Details
| Device ID | BK160112 |
| 510k Number | BK160112 |
| 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 | 2016-11-10 |
| Decision Date | 2017-04-07 |
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