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 IDBK200478
510k NumberBK200478
Device Name:Automated Blood Cell Separators
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Fresenius Kabi AG else-kroner-strasse 1 Bad Homburg,  61346,  GM
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-10
Decision Date2020-05-07

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