Empty Containers For The Collection & Processing Of Blood/Blood Components

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

One Lambda, Inc.

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

Pre-market Notification Details

Device IDBK910021
510k NumberBK910021
Device Name:Empty Containers For The Collection & Processing Of Blood/Blood Components
ClassificationContainer, Empty, For Collection & Processing Of Blood & Blood Components
Applicant One Lambda, Inc. 21001 Kittridge St. Canoga Park,  CA  91303
Product CodeKSR  
CFR Regulation Number864.9100 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-04
Decision Date1992-06-08

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