K-number	DEN170047
Device name	Curetis Unyvero LRT Application
Applicant	Curetis GmbH
Product code	QBH
Device class	Class II
Decision date	Apr 3, 2018
Decision	Not Substantially Equivalent
Regulation	866.3985

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View the full FDA submission: accessdata.fda.gov

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Curetis Unyvero LRT Application

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