510(k) Report

Devices descending from K925277

6 later devices reach Ciba Corning Acs HCG Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.20182—
+1K130020Access Total BHCG (5TH IS)Beckman Coulter, Inc.20132—
+2K221990Access Total ßhCG (5th IS)Beckman Coulter, Inc.20220—
+2K200210ADVIA Centaur® Total hCG assaySiemens Healthcare Diagnostics, Inc.20210—
+2K192547Maglumi 2000 HCG/ß-HCGShenzhen New Industries Biomedical Engineering Co., Ltd.20200—
+2K192790Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.20190—