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 IDBK080048
510k NumberBK080048
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) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-09
Decision Date2008-10-02

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