BreathID Hp System

FDA 510(k) K173772 · Exalenz Bioscience , Ltd.

Substantially Equivalent

510(k) numberK173772

Submission

Device name
BreathID Hp System
Applicant
Exalenz Bioscience , Ltd.
Modiin, IL
Received
December 12, 2017
Decision date
March 8, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 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
K220494BreathID Hp Lab System, BreathID Smart SystemMSQ · Special Meridian Bioscience Israel , Ltd.06/23/2022SE
K193610BreathID Smart SystemMSQ · Special Exalenz Bioscience , Ltd.02/06/2020SE
K173777BreathID Hp Lab 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
K193610BreathID Smart SystemMSQ · Special 02/06/2020SE
K173777BreathID Hp Lab SystemMSQ · Traditional 03/08/2018SE
K162150BreathID Hp Lab SystemMSQ · Traditional 10/31/2016SE
K130524Breathid HP SystemMSQ · Traditional 05/22/2013SE

Questions and answers

When was BreathID Hp System cleared by the FDA?

BreathID Hp System (K173772) received a 510(k) decision of Substantially Equivalent on March 8, 2018, 86 days after the submission was received.

What is the product code of K173772?

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