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MSQ — Test, Urea (Breath Or Blood) Class I

FDA Device Classification

Classification Details

Product Code
MSQ
Device Class
Class I
Regulation Number
866.3110
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K221896meridian bioscience israelBreathID Hp SystemDecember 19, 2022
K223185meridian bioscience israelBreathID® Smart SystemNovember 10, 2022
K220494meridian bioscience israelBreathID Hp Lab System, BreathID Smart SystemJune 23, 2022
K193610exalenz bioscienceBreathID Smart SystemFebruary 6, 2020
K173777exalenz bioscienceBreathID Hp Lab SystemMarch 8, 2018
K173772exalenz bioscienceBreathID Hp SystemMarch 8, 2018
K162150exalenz bioscienceBreathID Hp Lab SystemOctober 31, 2016
K130524exalenz bioscienceBREATHID HP SYSTEMMay 22, 2013
K093834hema metricsCRIT-LINE ANEMIA MANAGEMENT SOFTWARESeptember 29, 2010
K092817otsuka pharmaceutical coPOC-AS10 AUTO SAMPLERMarch 9, 2010
K041148otsuka pharmaceutical coPOCONE INFRARED SPECTROPHOTOMETERJuly 15, 2004
K014225meretek diagnosticsBREATHTEK - UBIT UBT FOR H. PYLORIJanuary 17, 2002
K011668oridion medical 1987VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORIJuly 9, 2001
K000316meretekMERETEK UBT_LITE BREATH TEST FOR H. PYLORIFebruary 24, 2000
K990931metabolic solutionsEZ-HBT HELICOBACTER BLOOD TESTSeptember 24, 1999
K973000alimentericsALIMENTERICS LARA (TM) BREATH TEST SYSTEMFebruary 26, 1998
K972352meretek diagnosticsTHE MERETEK UBT BREATH TEST FOR H.PYLORIOctober 29, 1997