510(k) Report

Devices descending from K182559

3 later devices reach PREMIER Platinum HpSA PLUS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc.20230—
+1K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc.20230—
+1K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.20200—