K-number	K191967
Device name	Unyvero LRT BAL Application
Applicant	Curetis GmbH
Product code	QBH
Device class	Class II
Decision date	Dec 20, 2019
Decision	Substantially Equivalent
Regulation	866.3985

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View the full FDA submission: accessdata.fda.gov

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Unyvero LRT BAL Application

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