510(k) Report

Devices descending from K130020

2 later devices reach Access Total BHCG (5TH IS) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221990Access Total ßhCG (5th IS)Beckman Coulter, Inc.20220—
+1K192547Maglumi 2000 HCG/ß-HCGShenzhen New Industries Biomedical Engineering Co., Ltd.20200—