The following data is part of a premarket notification filed by Fresenius Kabi with the FDA for Kit, Bone Marrow Collection.
| Device ID | BK160042 |
| 510k Number | BK160042 |
| Device Name: | Kit, Bone Marrow Collection |
| Classification | Bone Marrow Collection/transfusion Kit |
| Applicant | Fresenius Kabi three Corporate Drive Lake Zurich, IL 60047 |
| Product Code | LWE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-12 |
| Decision Date | 2016-06-09 |