510(k) Report

Devices descending from K020798

3 later devices reach Hemochron JR. Signature + through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050016Hemochron Signature EliteInternational Technidyne Corp.20052—
+2K193041Hemochron Signature EliteAccriva Diagnostics, Inc.20191—
+3K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…Accriva Diagnostics, Inc.202101