Name: Predicase
Price: 199 USD

K-number	K171441
Device name	ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
Applicant	Luminex Corporation
Product code	OZN
Device class	Class II
Decision date	Jul 21, 2017
Decision	Substantially Equivalent
Regulation	866.3130

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Source

View the full FDA submission: accessdata.fda.gov

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ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit

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