Blood Bank Supplies
Supplies, Blood-bank
Fresenius Kabi USA LLC.
The following data is part of a premarket notification filed by Fresenius Kabi Usa Llc. with the FDA for Blood Bank Supplies.
Pre-market Notification Details
Device ID | BK110012 |
510k Number | BK110012 |
Device Name: | Blood Bank Supplies |
Classification | Supplies, Blood-bank |
Applicant | Fresenius Kabi USA LLC. three Corporate Drive Lake Zurich, IL 60047 |
Product Code | KSS |
CFR Regulation Number | 864.9050 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-03-14 |
Decision Date | 2012-08-02 |
NIH GUDID Devices
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