BreathID Hp Lab System, BreathID Smart System

FDA 510(k) K220494 · Meridian Bioscience Israel , Ltd.

Substantially Equivalent

510(k) numberK220494

Submission

Device name
BreathID Hp Lab System, BreathID Smart System
Applicant
Meridian Bioscience Israel , Ltd.
Modiin, IL
Received
February 22, 2022
Decision date
June 23, 2022
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MSQ – Test, Urea (Breath Or Blood)
Device class
Class I (low risk)
Regulation
21 CFR 866.3110
Specialty
Microbiology

Other 510(k)s with product code MSQ

510(k)DeviceApplicantDecision
K221896BreathID Hp SystemMSQ · Special Meridian Bioscience Israel , Ltd.12/19/2022SE
K223185BreathID® Smart SystemMSQ · Special Meridian Bioscience Israel , Ltd.11/10/2022SE
K193610BreathID Smart SystemMSQ · Special Exalenz Bioscience , Ltd.02/06/2020SE
K173777BreathID Hp Lab SystemMSQ · Traditional Exalenz Bioscience , Ltd.03/08/2018SE
K173772BreathID Hp SystemMSQ · Traditional Exalenz Bioscience , Ltd.03/08/2018SE
K162150BreathID Hp Lab SystemMSQ · Traditional Exalenz Bioscience , Ltd.10/31/2016SE
K130524Breathid HP SystemMSQ · Traditional Exalenz Bioscience , Ltd.05/22/2013SE
K093834Crit-Line Anemia Management SoftwareMSQ · Traditional Hema Metrics, LLC09/29/2010SE
K092817POC-AS10 Auto SamplerMSQ · Traditional Otsuka Pharmaceutical Co., Ltd.03/09/2010SE
K041148Pocone Infrared SpectrophotometerMSQ · Traditional Otsuka Pharmaceutical Co., Ltd.07/15/2004SE

More from Otsuka Pharmaceutical Co., Ltd.

510(k)DeviceDecision
K221896BreathID Hp SystemMSQ · Special 12/19/2022SE
K223185BreathID® Smart SystemMSQ · Special 11/10/2022SE

Questions and answers

When was BreathID Hp Lab System, BreathID Smart System cleared by the FDA?

BreathID Hp Lab System, BreathID Smart System (K220494) received a 510(k) decision of Substantially Equivalent on June 23, 2022, 121 days after the submission was received.

What is the product code of K220494?

The FDA product code is MSQ – Test, Urea (Breath Or Blood), a Class I (low risk) device regulated under 21 CFR 866.3110.