510(k) Report

Devices descending from K983255

10 later devices reach Modification to: Premier Platinum Hpsa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053335Premier Platinum Hpsa Plus, Models 601396, 601480Meridian Bioscience, Inc.20066—
+1K032222Immunocardstat HpsaMeridian Bioscience, Inc.20032—
+2K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc.20190—
+2K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc.20183—
+2K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc.20180—
+2K181379H. Pylori Quik ChekTechlab, Inc.20180—
+2K181400H. Pylori Chek™Techlab, Inc.20180—
+3K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc.20230—
+3K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc.20230—
+3K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.20200—