The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Coaguchek Xs Plus System.
| Device ID | K071041 |
| 510k Number | K071041 |
| Device Name: | COAGUCHEK XS PLUS SYSTEM |
| Classification | Test, Time, Prothrombin |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Theresa Bush |
| Correspondent | Theresa Bush Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-12 |
| Decision Date | 2007-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00365702164109 | K071041 | 000 |
| 04015630945726 | K071041 | 000 |