Name: Predicase
Price: 199 USD

K-number	K083080
Device name	IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM
Applicant	Sqi Diagnostics Systems
Product code	DHR
Device class	Class II
Decision date	Oct 29, 2009
Decision	Substantially Equivalent
Regulation	866.5775

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Source

View the full FDA submission: accessdata.fda.gov

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IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM

Everything you need for a 510(k) submission. Nothing you don't.