510(k) Report

Devices descending from K120977

1 later device reach Directcheck Control for Hemochron JR. Microcoagulation Systems Act-LR Cuvette… through their predicates, nearest generation first.

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