510(k) Report

Devices descending from DEN150057

4 later devices reach Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203757Elecsys AMHRoche Diagnostics20220—
+1K170524Access AMHBeckman Coulter, Inc.20172—
+2K221801ADVIA Centaur® Anti-Müllerian Hormone (AMH)Siemens Healthcare Diagnostics, Inc.20230—
+2K223679Access AMHBeckman Coulter, Inc.20230—