The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Coaguchek Xs Pro System.
| Device ID | K180693 |
| 510k Number | K180693 |
| Device Name: | CoaguChek XS Pro System |
| Classification | Test, Time, Prothrombin |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Angie Clements |
| Correspondent | Angie Clements Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-16 |
| Decision Date | 2018-04-19 |