510(k) Report

Devices descending from K962571

4 later devices reach Coaguchek PST System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030845Coaguchek PT.S Test for Prothrombin Time Self-TestingRoche Diagnostics Corp.200331
+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—