BreathID Hp Lab System— 510(k) K173777

Substantially Equivalent

Exalenz Bioscience , Ltd.

FDA 510(k) clearance K173777 for BreathID Hp Lab System, Substantially Equivalent on 2018-03-08. Applicant: Exalenz Bioscience , Ltd..

Clearance details

Applicant: Exalenz Bioscience , Ltd.
Product code: Code MSQ
Advisory panel: Microbiology
Date received: 2017-12-12
Decision date: 2018-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Modiin, IL

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