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 IDBK110012
510k NumberBK110012
Device Name:Blood Bank Supplies
ClassificationSupplies, Blood-bank
Applicant Fresenius Kabi USA LLC. three Corporate Drive Lake Zurich,  IL  60047
Product CodeKSS  
CFR Regulation Number864.9050 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-14
Decision Date2012-08-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04086000860581 BK110012 0
04086000860475 BK110012 0

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