510(k) Report

Devices descending from K000463

3 later devices reach Immulite H. Pylori Igg and Immulite 2000 H. Pylori Igg through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161139LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetDiaSorin, Inc.20161—
+1K041238Helicobacter Pylori Igg ElisaBiohit Plc20040—
+2K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc.20180—