The following data is part of a premarket notification filed by Coagusense, Inc. with the FDA for Coag-sense Prothrombin Time (pt) / Inr Monitoring Device.
| Device ID | K183255 |
| 510k Number | K183255 |
| Device Name: | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device |
| Classification | Test, Time, Prothrombin |
| Applicant | CoaguSense, Inc. 48377 Fremont Blvd. Suite #113 Fremont, CA 94538 |
| Contact | Robin Bush |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-21 |
| Decision Date | 2019-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860007370878 | K183255 | 000 |
| 00860007370861 | K183255 | 000 |
| 00850040656022 | K183255 | 000 |