BreathID Hp Lab System, BreathID Smart System— 510(k) K220494

Substantially Equivalent

Meridian Bioscience Israel , Ltd.

FDA 510(k) clearance K220494 for BreathID Hp Lab System, BreathID Smart System, Substantially Equivalent on 2022-06-23. Applicant: Meridian Bioscience Israel , Ltd..

Clearance details

Applicant: Meridian Bioscience Israel , Ltd.
Product code: Code MSQ
Advisory panel: Microbiology
Date received: 2022-02-22
Decision date: 2022-06-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Modiin, IL

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