BreathID Hp System— 510(k) K221896

Substantially Equivalent

Meridian Bioscience Israel , Ltd.

FDA 510(k) clearance K221896 for BreathID Hp System, Substantially Equivalent on 2022-12-19. Applicant: Meridian Bioscience Israel , Ltd..

Clearance details

Applicant: Meridian Bioscience Israel , Ltd.
Product code: Code MSQ
Advisory panel: Microbiology
Date received: 2022-06-30
Decision date: 2022-12-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Modiin, IL

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