Coagusense, Inc.

FDA Regulatory Profile

Coagusense, Inc. appears in FDA public data with 0 recalls, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on October 5, 2022.

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