K183255 is an FDA 510(k) clearance for the Coag-Sense Prothrombin Time (PT) / INR Monitoring Device. This device is classified as a Test, Time, Prothrombin (Class II - Special Controls, product code GJS).
Submitted by Coagusense, Inc. (Fremont, US). The FDA issued a Cleared decision on February 21, 2019, 92 days after receiving the submission on November 21, 2018.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7750.
| 510(k) Number | K183255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2018 |
| Decision Date | February 21, 2019 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GJS - Test, Time, Prothrombin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7750 |