The following data is part of a premarket notification filed by Fresenius Kabi Usa Llc. with the FDA for Automated Blood Cell Separators.
Device ID | BK150357 |
510k Number | BK150357 |
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 | 2015-12-17 |
Decision Date | 2016-04-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14086000101384 | BK150357 | 0 |
14086000101377 | BK150357 | 0 |
10810020440161 | BK150357 | 0 |
00810020440140 | BK150357 | 0 |