Qualitative Test For HLA, Non-diagnostic

Test, Qualitative, For Hla, Non-diagnostic

Microdrop, Incorporation

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

Pre-market Notification Details

Device IDBK840013
510k NumberBK840013
Device Name:Qualitative Test For HLA, Non-diagnostic
ClassificationTest, Qualitative, For Hla, Non-diagnostic
Applicant Microdrop, Incorporation 2227 Corinth Ave. Los Angeles,  CA  90064
Product CodeMZI  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-11-02
Decision Date1984-11-20

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