Cleared Traditional

BreathID Hp System

K173772 · Exalenz Bioscience , Ltd. · Microbiology
Mar 2018
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K173772 is an FDA 510(k) clearance for the BreathID Hp System, a Test, Urea (breath Or Blood) (Class I — General Controls, product code MSQ), submitted by Exalenz Bioscience , Ltd. (Modiin, IL). The FDA issued a Cleared decision on March 8, 2018, 86 days after receiving the submission on December 12, 2017. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K173772 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2017
Decision Date March 08, 2018
Days to Decision 86 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MSQ — Test, Urea (breath Or Blood)
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3110

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