Cleared Special

BreathID Hp System

K221896 · Meridian Bioscience Israel , Ltd. · Microbiology

Dec 2022

Decision

172d

Days

Class 1

Risk

About This 510(k) Submission

K221896 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 Meridian Bioscience Israel , Ltd. (Modiin, IL). The FDA issued a Cleared decision on December 19, 2022, 172 days after receiving the submission on June 30, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3110.

Submission Details

510(k) Number	K221896 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2022
Decision Date	December 19, 2022
Days to Decision	172 days
Submission Type	Special
Review Panel	Microbiology (MI)
Summary	Summary PDF