510(k) Report

Devices descending from K940401

5 later devices reach JR. Microcoagulation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974799Hemochron JR Generation II, Hemochron JR SignatureInternational Technidyne Corp.199842
+2K020798Hemochron JR. Signature +International Technidyne Corp.20023—
+3K050016Hemochron Signature EliteInternational Technidyne Corp.20052—
+4K193041Hemochron Signature EliteAccriva Diagnostics, Inc.20191—
+5K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…Accriva Diagnostics, Inc.202101