Automated Blood Cell Separators

Separator, Automated, Blood Cell, Diagnostic

Fresenius Kabi AG

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

Pre-market Notification Details

Device IDBK170057
510k NumberBK170057
Device Name:Automated Blood Cell Separators
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Fresenius Kabi AG three Corporate Dr Lake Zurich,  IL  60047 US
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductYes
Date Received2017-06-02
Decision Date2017-08-25

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