The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Coaguchek Xs System.
| Device ID | K062925 |
| 510k Number | K062925 |
| Device Name: | COAGUCHEK XS SYSTEM |
| Classification | Test, Time, Prothrombin |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46256 |
| Contact | Theresa Bush |
| Correspondent | Theresa Bush ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, 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 | 2006-09-28 |
| Decision Date | 2007-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00365702127104 | K062925 | 000 |
| 00365702125100 | K062925 | 000 |
| 04015630945689 | K062925 | 000 |