BreathID Hp Lab System— 510(k) K162150

Substantially Equivalent

Exalenz Bioscience , Ltd.

FDA 510(k) clearance K162150 for BreathID Hp Lab System, Substantially Equivalent on 2016-10-31. Applicant: Exalenz Bioscience , Ltd..

Clearance details

Applicant: Exalenz Bioscience , Ltd.
Product code: Code MSQ
Advisory panel: Microbiology
Date received: 2016-08-02
Decision date: 2016-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Modiin, IL

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