Container, Empty, For The Collection '& Processing Of Blood/Blood Components

Container, Empty, For Collection & Processing Of Blood & Blood Components

Terumo BCT, Inc

The following data is part of a premarket notification filed by Terumo Bct, Inc with the FDA for Container, Empty, For The Collection '& Processing Of Blood/blood Components.

Pre-market Notification Details

Device IDBK210658
510k NumberBK210658
Device Name:Container, Empty, For The Collection '& Processing Of Blood/Blood Components
ClassificationContainer, Empty, For Collection & Processing Of Blood & Blood Components
Applicant Terumo BCT, Inc 10811 W. Collins Ave. Lakewood,  CO  80215
Product CodeKSR  
CFR Regulation Number864.9100 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-02
Decision Date2022-08-26

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