Name: Predicase
Price: 199 USD

K-number	K161495
Device name	ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
Applicant	Luminex Corporation
Product code	OOI
Device class	Class II
Decision date	Jun 30, 2016
Decision	Substantially Equivalent
Regulation	862.2570

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Source

View the full FDA submission: accessdata.fda.gov

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ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)

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