Blood Bank Supplies

Supplies, Blood-bank

Fresenius Kabi AG

The following data is part of a premarket notification filed by Fresenius Kabi Ag with the FDA for Blood Bank Supplies.

Pre-market Notification Details

Device IDBK190413
510k NumberBK190413
Device Name:Blood Bank Supplies
ClassificationSupplies, Blood-bank
Applicant Fresenius Kabi AG else-kroner-strasse 1 Bad Homburg,  61352,  GM
Product CodeKSS  
CFR Regulation Number864.9050 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-12
Decision Date2020-02-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04086000860161 BK190413 0

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.