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 IDBK100044
510k NumberBK100044
Device Name:Automated Blood Cell Separators
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) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-09
Decision Date2010-07-30

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