510(k) Report

Devices descending from K020679

6 later devices reach Inratio through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110212INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test StripAlere San Diego, Inc (Formally Biosite Incorporate20120Class I
+1K072727Inratio 2 PT Monitoring SystemHemosense, Inc.20075Class I
+2K092987Inratio/INRATIO2 Test StripsBiosite Incorporated20101Class I
+2K093243Coagusense Self-Test Prothrombin Time/Inr Monitoring SystemCoagusense, Inc.201021
+3K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc.201911
+4K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingCoagusense, Inc.20220—