510(k) K183255 ยท GJS Test, Time, Prothrombin
Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
| Applicant | Coagusense, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Feb 21, 2019 |
| Received | Nov 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183255
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50.
b. Coagulation Control Kit Coag-Sense PT / INR T Open, Classified |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.