510(k) Report

Devices descending from K032222

2 later devices reach Immunocardstat Hpsa through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc.20190—
+1K181379H. Pylori Quik ChekTechlab, Inc.20180—