The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Coaguchek Vantus System.
| Device ID | K170960 |
| 510k Number | K170960 |
| Device Name: | CoaguChek Vantus System |
| Classification | Test, Time, Prothrombin |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Justin Davis |
| Correspondent | Justin Davis Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-31 |
| Decision Date | 2017-12-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00365702700499 | K170960 | 000 |
| 00365702702356 | K170960 | 000 |