IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM— 510(k) K083080

Name: FDA 510(k) clearance K083080
Creator: U.S. Food and Drug Administration
Published: 2009-10-29

Substantially Equivalent

Sqi Diagnostics Systems

FDA 510(k) clearance K083080 for IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM, Substantially Equivalent on 2009-10-29. Applicant: Sqi Diagnostics Systems. Device class: 2.

Clearance details

Applicant: Sqi Diagnostics Systems
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 2008-10-16
Decision date: 2009-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, On, CA

Download summary PDF View on FDA.gov ↗

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