The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Coaguchek Xs System.
| Device ID | K060978 |
| 510k Number | K060978 |
| Device Name: | COAGUCHEK XS SYSTEM |
| Classification | Test, Time, Prothrombin |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianap0lis, IN 46256 |
| Contact | Jennifer Tribbett |
| Correspondent | Jennifer Tribbett Roche Diagnostics 9115 HAGUE ROAD Indianap0lis, IN 46256 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-10 |
| Decision Date | 2006-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00365702128101 | K060978 | 000 |
| 00365702126107 | K060978 | 000 |