K-number	DEN180030
Device name	QMS Plazomicin Immunoassay
Applicant	Microgenics Corporation
Product code	QDR
Device class	Class II
Decision date	Nov 19, 2018
Decision	Not Substantially Equivalent
Regulation	862.3460

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View the full FDA submission: accessdata.fda.gov

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QMS Plazomicin Immunoassay

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