K-number	K191352
Device name	binx health io CT/NG Assay
Applicant	Binx Health, Inc.
Product code	QEP
Device class	Class II
Decision date	Aug 8, 2019
Decision	Substantially Equivalent
Regulation	866.3393

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Source

View the full FDA submission: accessdata.fda.gov

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binx health io CT/NG Assay

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