BreathID® Smart System— 510(k) K223185

Substantially Equivalent

Meridian Bioscience Israel , Ltd.

FDA 510(k) clearance K223185 for BreathID® Smart System, Substantially Equivalent on 2022-11-10. Applicant: Meridian Bioscience Israel , Ltd..

Clearance details

Applicant: Meridian Bioscience Israel , Ltd.
Product code: Code MSQ
Advisory panel: Microbiology
Date received: 2022-10-12
Decision date: 2022-11-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Modiin, IL

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