Qualitative Test For HLA, Non-diagnostic

Test, Qualitative, For Hla, Non-diagnostic

Genetic Systems Corporation

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

Pre-market Notification Details

Device IDBK870006
510k NumberBK870006
Device Name:Qualitative Test For HLA, Non-diagnostic
ClassificationTest, Qualitative, For Hla, Non-diagnostic
Applicant Genetic Systems Corporation 3005 First Avenue Seattle,  WA  98121
Product CodeMZI  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-01
Decision Date1987-07-20

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