Test, Qualitative, 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 Test, Qualitative, For Hla, Non-diagnostic.

Pre-market Notification Details

Device IDBK200546
510k NumberBK200546
Device Name:Test, Qualitative, For HLA, Non-Diagnostic
ClassificationTest, Qualitative, For Hla, Non-diagnostic
Applicant One Lambda, Inc. 22801 Roscoe Blvd West Hills,  CA  92304
Product CodeMZI  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Special
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-10
Decision Date2021-01-07

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