Qualitative Test For HLA, Non-diagnostic

Test, Qualitative, For Hla, Non-diagnostic

Life Technologies Corporation

The following data is part of a premarket notification filed by Life Technologies Corporation with the FDA for Qualitative Test For Hla, Non-diagnostic.

Pre-market Notification Details

Device IDBK110038
510k NumberBK110038
Device Name:Qualitative Test For HLA, Non-diagnostic
ClassificationTest, Qualitative, For Hla, Non-diagnostic
Applicant Life Technologies Corporation 9099 North Deerbrook Trail Brown Deer,  WI  53223
Product CodeMZI  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-02
Decision Date2013-02-05

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