510(k) K212779 ยท GJS Test, Time, Prothrombin
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
| Applicant | Coagusense, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Oct 5, 2022 |
| Received | Sep 1, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212779
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.