510(k) Report

Devices descending from K952220

11 later devices reach Meretek Breath Test for H.Pylori Collection Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011668Validation of the Breathid System, for the Detection of Helicbactor PyloriOridion Medical 1987, Ltd.20018—
+1K990931EZ-HBT Helicobacter Blood TestMetabolic Solutions, Inc.19990—
+1K972352The Meretek Ubt Breath Test for H.PyloriMeretek Diagnostics, Inc.19979—
+2K130524Breathid HP SystemExalenz Bioscience, Ltd.20137—
+3K173772BreathID Hp SystemExalenz Bioscience, Ltd.20181—
+3K162150BreathID Hp Lab SystemExalenz Bioscience, Ltd.20164—
+4K221896BreathID Hp SystemMeridian Bioscience Israel, Ltd.20220—
+4K173777BreathID Hp Lab SystemExalenz Bioscience, Ltd.20183—
+5K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel, Ltd.20221—
+5K193610BreathID Smart SystemExalenz Bioscience, Ltd.20202—
+6K223185BreathID® Smart SystemMeridian Bioscience Israel, Ltd.20220—