The following data is part of a premarket notification filed by Coagusense, Inc with the FDA for Coagusense Self-test Prothrombin Time/inr Monitoring System.
| Device ID | K093243 |
| 510k Number | K093243 |
| Device Name: | COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM |
| Classification | Test, Time, Prothrombin |
| Applicant | COAGUSENSE, INC 42840 CHRISTY ST SUITE 110 Fremont, CA 94538 |
| Contact | Douglas Paterson |
| Correspondent | Douglas Paterson COAGUSENSE, INC 42840 CHRISTY ST SUITE 110 Fremont, CA 94538 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-15 |
| Decision Date | 2010-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861900000343 | K093243 | 000 |
| 00861900000336 | K093243 | 000 |
| 00861900000329 | K093243 | 000 |