510(k) Report

Devices descending from K053335

6 later devices reach Premier Platinum Hpsa Plus, Models 601396, 601480 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc.20183—
+1K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc.20180—
+1K181400H. Pylori Chek™Techlab, Inc.20180—
+2K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc.20230—
+2K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc.20230—
+2K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.20200—