510(k) Report

Devices descending from P060035

2 later devices reach Architect Core-M Reagent Kit/Calibrators/Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260049Elecsys Anti-HBc IgMRoche Diagnostics20260—
+1K254059Access anti-HBc IgMBeckman Coulter, Inc.20260—