The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Coaguchek Xs Pt Controls.
| Device ID | K063823 |
| 510k Number | K063823 |
| Device Name: | COAGUCHEK XS PT CONTROLS |
| Classification | Plasma, Coagulation Control |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Theresa Ambrose Bush |
| Correspondent | Theresa Ambrose Bush ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-26 |
| Decision Date | 2007-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00365702129108 | K063823 | 000 |