IGX PLEX CELIAC QUALITATIVE ASSAY— 510(k) K102490

Name: FDA 510(k) clearance K102490
Creator: U.S. Food and Drug Administration
Published: 2011-06-02

Substantially Equivalent

Sqi Diagnostics Systems

FDA 510(k) clearance K102490 for IGX PLEX CELIAC QUALITATIVE ASSAY, Substantially Equivalent on 2011-06-02. Applicant: Sqi Diagnostics Systems. Device class: 2.

Clearance details

Applicant: Sqi Diagnostics Systems
Product code: Code MVM
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2010-08-31
Decision date: 2011-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, On, CA

Download summary PDF View on FDA.gov ↗

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