Qualitative Test For HLA, Non-diagnostic

Test, Qualitative, For Hla, Non-diagnostic

One Lambda, Inc.

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

Pre-market Notification Details

Device IDBK100068
510k NumberBK100068
Device Name:Qualitative Test For HLA, Non-diagnostic
ClassificationTest, Qualitative, For Hla, Non-diagnostic
Applicant One Lambda, Inc. 21001 Kittridge St. Canoga Park,  CA  91303
Product CodeMZI  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-24
Decision Date2011-08-25

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