Processing Systems For Frozen Blood
System, Processing For Frozen Blood
Fresenius Kabi AG
The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Processing Systems For Frozen Blood.
Pre-market Notification Details
| Device ID | BK180254 |
| 510k Number | BK180254 |
| Device Name: | Processing Systems For Frozen Blood |
| Classification | System, Processing For Frozen Blood |
| Applicant | Fresenius Kabi AG three Corporate Dr Lake Zurich, IL 60047 US |
| Product Code | KSW |
| CFR Regulation Number | 864.9145 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-04 |
| Decision Date | 2018-12-03 |
NIH GUDID Devices
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