FDA 510(k) Applications for Medical Device Product Code: MSQ (Test, Urea (Breath Or Blood))

FDA 510(k) Applications for Medical Device Product Code "MSQ"
(Test, Urea (Breath Or Blood))

FDA 510(k) Number	Applicant	Device Name	Decision Date
K973000	ALIMENTERICS, INC.	ALIMENTERICS LARA (TM) BREATH TEST SYSTEM	02/26/1998
K173777	Exalenz Bioscience Ltd.	BreathID Hp Lab System	03/08/2018
K162150	Exalenz Bioscience Ltd.	BreathID Hp Lab System	10/31/2016
K130524	EXALENZ BIOSCIENCE LTD.	BREATHID HP SYSTEM	05/22/2013
K173772	Exalenz Bioscience Ltd.	BreathID Hp System	03/08/2018
K193610	Exalenz Bioscience Ltd.	BreathID Smart System	02/06/2020
K093834	HEMA METRICS, LLC	CRIT-LINE ANEMIA MANAGEMENT SOFTWARE	09/29/2010
K000316	MERETEK	MERETEK UBT_LITE BREATH TEST FOR H. PYLORI	02/24/2000
K014225	MERETEK DIAGNOSTICS, INC.	BREATHTEK - UBIT UBT FOR H. PYLORI	01/17/2002
K972352	MERETEK DIAGNOSTICS, INC.	THE MERETEK UBT BREATH TEST FOR H.PYLORI	10/29/1997
K220494	Meridian Bioscience Israel Ltd.	BreathID Hp Lab System, BreathID Smart System	06/23/2022
K221896	Meridian Bioscience Israel Ltd.	BreathID Hp System	12/19/2022
K223185	Meridian Bioscience Israel Ltd.	BreathID« Smart System	11/10/2022
K990931	METABOLIC SOLUTIONS, INC.	EZ-HBT HELICOBACTER BLOOD TEST	09/24/1999
K011668	ORIDION MEDICAL 1987 LTD.	VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI	07/09/2001
K092817	OTSUKA PHARMACEUTICAL CO., LTD.	POC-AS10 AUTO SAMPLER	03/09/2010
K041148	OTSUKA PHARMACEUTICAL CO., LTD.	POCONE INFRARED SPECTROPHOTOMETER	07/15/2004