The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Accu-chek Go System.
| Device ID | K040796 |
| 510k Number | K040796 |
| Device Name: | ACCU-CHEK GO SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Scott Thiel |
| Correspondent | Scott Thiel ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-29 |
| Decision Date | 2004-04-22 |
| Summary: | summary |