IG_PLEX CELIAC DGP PANEL— 510(k) K140691

Name: FDA 510(k) clearance K140691
Creator: U.S. Food and Drug Administration
Published: 2014-11-06

Substantially Equivalent

Sqi Diagnostics Systems, Inc.

FDA 510(k) clearance K140691 for IG_PLEX CELIAC DGP PANEL, Substantially Equivalent on 2014-11-06. Applicant: Sqi Diagnostics Systems, Inc.. Device class: 2.

Clearance details

Applicant: Sqi Diagnostics Systems, Inc.
Product code: Code MVM
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2014-03-19
Decision date: 2014-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, On, CA

Download summary PDF View on FDA.gov ↗

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