Automated Blood Cell Separators

Separator, Automated, Blood Cell, Diagnostic

Fresenius Kabi USA LLC.

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

Pre-market Notification Details

Device IDBK150288
510k NumberBK150288
Device Name:Automated Blood Cell Separators
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Fresenius Kabi USA LLC. three Corporate Drive Lake Zurich,  IL  60047
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-01
Decision Date2015-08-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14086000100998 BK150288 0
04086000100984 BK150288 0

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