Clearance Summary
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing received FDA 510(k) clearance under submission number K212779, sponsored by Coagusense, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2022-10-05.
- Submission: K212779
- Applicant / Sponsor: Coagusense, Inc.
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7750
- Decision date: 2022-10-05
Classification & Regulation
This clearance is catalogued under FDA product code GJS and 21 CFR 864.7750, within the Hematology review panel as a Class II device.