510(k) Report

Devices descending from K960749

3 later devices reach Hemochron JR. Microcoagulation Low Range 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—
+1K992851Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro SystemRoche Diagnostics Corp.20000—