K-number	K242613
Device name	NxTAG® Respiratory Pathogen Panel
Applicant	Luminex Molecular Diagnostics, Inc.
Product code	OCC
Device class	Class II
Decision date	Oct 2, 2024
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

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