510(k) Report

Devices descending from K030845

3 later devices reach Coaguchek PT.S Test for Prothrombin Time Self-Testing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093243Coagusense Self-Test Prothrombin Time/Inr Monitoring SystemCoagusense, Inc.201021
+2K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceCoagusense, Inc.201911
+3K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingCoagusense, Inc.20220—