K-number	K173725
Device name	NeuMoDx GBS Assay
Applicant	Neumodx Molecular, Inc.
Product code	NJR
Device class	Class I
Decision date	Jun 26, 2018
Decision	Substantially Equivalent
Regulation	866.3740

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View the full FDA submission: accessdata.fda.gov

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NeuMoDx GBS Assay

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