Cleared Special

BreathID Hp Lab System, BreathID Smart System

K220494 · Meridian Bioscience Israel , Ltd. · Microbiology
Jun 2022
Decision
121d
Days
Class 1
Risk

About This 510(k) Submission

K220494 is an FDA 510(k) clearance for the BreathID Hp Lab System, 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 June 23, 2022, 121 days after receiving the submission on February 22, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number K220494 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2022
Decision Date June 23, 2022
Days to Decision 121 days
Submission Type Special
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