FDA.reportPublic FDA data

510(k) K173777

Device
BreathID Hp Lab System
Applicant
Exalenz Bioscience Ltd.
510(k) number
K173777
Product code
MSQ  
Decision
Substantially Equivalent (SESE)
Decision date
2018-03-08
Date received
2017-12-12
Regulation
866.3110
Classification name
Test, Urea (breath Or Blood)
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Raffi Werner
Address
4 Ha'Maayan St. Modiin IL 7177872 7177872

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MSQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221896BreathID Hp SystemMeridian Bioscience Israel , Ltd.2022-12-19
K223185BreathID® Smart SystemMeridian Bioscience Israel , Ltd.2022-11-10
K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel , Ltd.2022-06-23
K193610BreathID Smart SystemExalenz Bioscience , Ltd.2020-02-06
K173772BreathID Hp SystemExalenz Bioscience , Ltd.2018-03-08
K162150BreathID Hp Lab SystemExalenz Bioscience , Ltd.2016-10-31
K130524BREATHID HP SYSTEMExalenz Bioscience , Ltd.2013-05-22
K093834CRIT-LINE ANEMIA MANAGEMENT SOFTWAREHema Metrics, LLC2010-09-29
K092817POC-AS10 AUTO SAMPLEROtsuka Pharmaceutical Co., Ltd.2010-03-09
K041148POCONE INFRARED SPECTROPHOTOMETEROtsuka Pharmaceutical Co., Ltd.2004-07-15
K014225BREATHTEK - UBIT UBT FOR H. PYLORIMeretek Diagnostics, Inc.2002-01-17
K011668VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORIOridion Medical 1987 , Ltd.2001-07-09
K000316MERETEK UBT_LITE BREATH TEST FOR H. PYLORIMeretek2000-02-24
K990931EZ-HBT HELICOBACTER BLOOD TESTMetabolic Solutions, Inc.1999-09-24
K973000ALIMENTERICS LARA (TM) BREATH TEST SYSTEMAlimenterics, Inc.1998-02-26

Legacy Summary#

summary

FDA Review#

Decision Summary