Cleared Traditional

IG_PLEX CELIAC DGP PANEL

K140691 · Sqi Diagnostics Systems, Inc. · Immunology
Nov 2014
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K140691 is an FDA 510(k) clearance for the IG_PLEX CELIAC DGP PANEL, a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Sqi Diagnostics Systems, Inc. (Toronto, On, CA). The FDA issued a Cleared decision on November 6, 2014, 232 days after receiving the submission on March 19, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K140691 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2014
Decision Date November 06, 2014
Days to Decision 232 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MVM — Autoantibodies, Endomysial(tissue Transglutaminase)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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