The following data is part of a premarket notification filed by Coagusense, Inc. with the FDA for Coag-sense Prothrombin (pt) / Inr Monitoring System For Patient Self-testing.
| Device ID | K212779 |
| 510k Number | K212779 |
| Device Name: | Coag-Sense Prothrombin (PT) / INR Monitoring System For Patient Self-Testing |
| Classification | Test, Time, Prothrombin |
| Applicant | CoaguSense, Inc. 48377 Fremont Blvd. Suite 113 Fremont, CA 94538 |
| Contact | Michael Acosta |
| Correspondent | Robin Bush CoaguSense, Inc. 48377 Fremont Blvd. Suite 113 Fremont, CA 94538 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-01 |
| Decision Date | 2022-10-05 |