Cleared Traditional

K162150 - BreathID Hp Lab System
(FDA 510(k) Clearance)

K162150 · Exalenz Bioscience , Ltd. · Microbiology

Oct 2016

Decision

90d

Days

Class 1

Risk

K162150 is an FDA 510(k) clearance for the BreathID Hp Lab System. This device is classified as 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 October 31, 2016, 90 days after receiving the submission on August 2, 2016.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number	K162150 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 2016
Decision Date	October 31, 2016
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF