510(k) Report

Devices descending from P080023

2 later devices reach Architect Core Reagent Kit, Architect Core Calibrator and Architect Core… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260046Elecsys Anti-HBc IIRoche Diagnostics20260—
+1K253687Access anti-HBc TotalBeckman Coulter, Inc.20260—