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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K083080
Device Name IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM
Applicant
Sqi Diagnostics Systems
36 Meteor Dr.
Toronto, On,  CA M9W 1A4
Applicant Contact Kate Smith
Correspondent
Sqi Diagnostics Systems
36 Meteor Dr.
Toronto, On,  CA M9W 1A4
Correspondent Contact Kate Smith
Regulation Number866.5775
Classification Product Code
DHR  
Subsequent Product Codes
NHX   NSU  
Date Received10/16/2008
Decision Date 10/29/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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