510(k) Report

Devices descending from K930068

2 later devices reach Hemochron Model 8000/Factor VI Premier Coagulation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983475Hemochron ResponseInternational Technidyne Corp.199911
+2K030818Hemochron Response/SystemInternational Technidyne Corp.20030—