Name: Predicase
Price: 199 USD

K-number	K193167
Device name	NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software
Applicant	Luminex Molecular Diagnostics, Inc.
Product code	OCC
Device class	Class II
Decision date	Dec 11, 2019
Decision	Substantially Equivalent
Regulation	866.3980

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Source

View the full FDA submission: accessdata.fda.gov

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NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software

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