510(k) Report

Devices descending from K190428

2 later devices reach Elecsys Anti-HAV II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242492Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG)…Techno-Path Manufacturing, Ltd.20250—
+1K243846Access anti-HAVBeckman Coulter, Inc.20250—