510(k) Report

Devices descending from P780012

6 later devices reach HAVAB through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100903Anti-HavRoche Professional Diagnostics20103—
+1K060678Vitros Immunodiagnostic Products Anti-Hav Total Reagent Pack,Calibrator,ControlsOrtho-Clinical Diagnostics, Inc.20061—
+2K190428Elecsys Anti-HAV IIRoche Diagnostics20192—
+2K142758ADVIA Centaur HAV total assaySiemens Healthcare Diagnostics, Inc.20140—
+3K242492Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG)…Techno-Path Manufacturing, Ltd.20250—
+3K243846Access anti-HAVBeckman Coulter, Inc.20250—