The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Automated Blood Cell Separators.
| Device ID | BK190368 |
| 510k Number | BK190368 |
| Device Name: | Automated Blood Cell Separators |
| Classification | Separator, Automated, Blood Cell, Diagnostic |
| Applicant | Fresenius Kabi AG else-kroner-strasse 1 Bad Homburg, 61346, GM |
| Product Code | GKT |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-28 |
| Decision Date | 2019-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810020440003 | BK190368 | 0 |
| 00810020440300 | BK190368 | 0 |