K-number	K200533
Device name	binx io CT/NG Assay and binx io CT/NG System
Applicant	Binx Health, Inc.
Product code	QEP
Device class	Class II
Decision date	Apr 27, 2020
Decision	Substantially Equivalent
Regulation	866.3393

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Source

View the full FDA submission: accessdata.fda.gov

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binx io CT/NG Assay and binx io CT/NG System

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