The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.
Device ID | BK180293 |
510k Number | BK180293 |
Device Name: | Empty Containers For The Collection & Processing Of Blood/Blood Components |
Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
Applicant | Fresenius Kabi AG three Corporate Dr Lake Zurich, IL 60047 US |
Product Code | KSR |
CFR Regulation Number | 864.9100 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-03 |
Decision Date | 2018-12-21 |