Automated Blood Cell Separators

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 Separators.

Pre-market Notification Details

Device IDBK080053
510k NumberBK080053
Device Name:Automated Blood Cell Separators
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Fenwal Inc three Corporate Drive 2nd Floor Lake Zurich,  IL  60047
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-29
Decision Date2008-12-22

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.