Cleared Special

BreathID? Smart System

K223185 · Meridian Bioscience Israel , Ltd. · Microbiology

Nov 2022

Decision

29d

Days

Class 1

Risk

About This 510(k) Submission

K223185 is an FDA 510(k) clearance for the BreathID? Smart System, a Test, Urea (breath Or Blood) (Class I — General Controls, product code MSQ), submitted by Meridian Bioscience Israel , Ltd. (Modiin, IL). The FDA issued a Cleared decision on November 10, 2022, 29 days after receiving the submission on October 12, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number	K223185 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 12, 2022
Decision Date	November 10, 2022
Days to Decision	29 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF