510(k) Report

Devices descending from K050016

2 later devices reach Hemochron Signature Elite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193041Hemochron Signature EliteAccriva Diagnostics, Inc.20191—
+2K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…Accriva Diagnostics, Inc.202101