510(k) Report

Devices descending from K941007

2 later devices reach Catalog NO. J-Act+ & QC-Act+ 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
+1K120977Directcheck Control for Hemochron JR. Microcoagulation Systems Act-LR Cuvette…International Technidyne Corp.20131—