Automated Blood Cell Separator -Filtration

Separator, Automated, Blood Cell, Diagnostic

Fresenius USA/Seratronics Inc.

The following data is part of a premarket notification filed by Fresenius Usa/seratronics Inc. with the FDA for Automated Blood Cell Separator -filtration.

Pre-market Notification Details

Device IDBK880007
510k NumberBK880007
Device Name:Automated Blood Cell Separator -Filtration
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Fresenius USA/Seratronics Inc. 2637 Shadelands Drive Walnut Creek,  CA  94598 US
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-27
Decision Date1996-07-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04052682000522 BK880007 000
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