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 IDBK130031
510k NumberBK130031
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) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-25
Decision Date2013-07-25

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