Automated Blood Cell Separator -Filtration

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 Separator -filtration.

Pre-market Notification Details

Device IDBK010050
510k NumberBK010050
Device Name:Automated Blood Cell Separator -Filtration
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) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-06
Decision Date2002-09-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.