Automated Blood Cell Separators

Separator, Automated, Blood Cell, Diagnostic

Terumo BCT, Inc

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

Pre-market Notification Details

Device IDBK150321
510k NumberBK150321
Device Name:Automated Blood Cell Separators
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant Terumo BCT, Inc 10811 W. Collins Ave. Lakewood,  CO  80215 US
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-17
Decision Date2015-10-16

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