510(k) Report

Devices descending from K974799

4 later devices reach Hemochron JR Generation II, Hemochron JR Signature through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020798Hemochron JR. Signature +International Technidyne Corp.20023—
+2K050016Hemochron Signature EliteInternational Technidyne Corp.20052—
+3K193041Hemochron Signature EliteAccriva Diagnostics, Inc.20191—
+4K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…Accriva Diagnostics, Inc.202101