Automated Blood Cell Separators

Separator, Automated, Blood Cell, Diagnostic

CaridianBCT

The following data is part of a premarket notification filed by Caridianbct with the FDA for Automated Blood Cell Separators.

Pre-market Notification Details

Device IDBK100032
510k NumberBK100032
Device Name:Automated Blood Cell Separators
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant CaridianBCT 10811 W. Collins Avenue Lakewood,  CO  80215
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-21
Decision Date2010-08-06

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