Automated Blood Cell Separator -Filtration

Separator, Automated, Blood Cell, Diagnostic

Fenwal Inc

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

Pre-market Notification Details

Device IDBK000039
510k NumberBK000039
Device Name:Automated Blood Cell Separator -Filtration
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Fenwal Inc three Corporate Drive Lake Zurich,  IL  60047
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-22
Decision Date2002-08-26

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