IG_PLEX CELIAC DGP PANEL

Autoantibodies, Endomysial(tissue Transglutaminase)

SQI DIAGNOSTICS SYSTEMS INC.

The following data is part of a premarket notification filed by Sqi Diagnostics Systems Inc. with the FDA for Ig_plex Celiac Dgp Panel.

Pre-market Notification Details

Device IDK140691
510k NumberK140691
Device Name:IG_PLEX CELIAC DGP PANEL
ClassificationAutoantibodies, Endomysial(tissue Transglutaminase)
Applicant SQI DIAGNOSTICS SYSTEMS INC. 36 Meteor Dr. Toronto, On,  CA M9w 1a4
ContactKate Smith
CorrespondentKate Smith
SQI DIAGNOSTICS SYSTEMS INC. 36 Meteor Dr. Toronto, On,  CA M9w 1a4
Product CodeMVM  
Subsequent Product CodeMST
Subsequent Product CodeNSU
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-19
Decision Date2014-11-06
Summary:summary

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