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510(k) K083080

IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM by Sqi Diagnostics Systems — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2009
Date Received
October 16, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

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