510(k) Report

Devices descending from K183255

1 later device reach Coag-Sense Prothrombin Time (PT) / INR Monitoring Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingCoagusense, Inc.20220—