Automated Blood Cell Separators

Separator, Automated, Blood Cell, Diagnostic

TERUMO BCT

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

Pre-market Notification Details

Device IDBK130065
510k NumberBK130065
Device Name:Automated Blood Cell Separators
ClassificationSeparator, Automated, Blood Cell, Diagnostic
Applicant TERUMO BCT 10811 W. Collins Ave Lakewood,  CO  80215
Product CodeGKT  
CFR Regulation Number864.9245 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-23
Decision Date2014-01-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
35020583103000 BK130065 0
05020583103009 BK130065 0

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