Coagusense, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingOctober 5, 2022
K183255Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceFebruary 21, 2019
K093243COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEMApril 7, 2010