K-number	K181156
Device name	Panther Fusion GBS Assay
Applicant	Diagenode
Product code	NJR
Device class	Class I
Decision date	Jul 27, 2018
Decision	Substantially Equivalent
Regulation	866.3740

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Source

View the full FDA submission: accessdata.fda.gov

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Panther Fusion GBS Assay

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