K-number	K220494
Device name	BreathID Hp Lab System, BreathID Smart System
Applicant	Meridian Bioscience Israel , Ltd.
Product code	MSQ
Device class	Class I
Decision date	Jun 23, 2022
Decision	Substantially Equivalent
Regulation	866.3110

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View the full FDA submission: accessdata.fda.gov

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BreathID Hp Lab System, BreathID Smart System

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