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 IDBK150236
510k NumberBK150236
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 Received2015-03-16
Decision Date2015-04-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00811137012992 BK150236 0
14086000101032 BK150236 0

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