The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Accu-chek Advisor Insulin Guidance Software.
| Device ID | K043529 |
| 510k Number | K043529 |
| Device Name: | ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE |
| Classification | Medical Computers And Software |
| 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 | LNX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-21 |
| Decision Date | 2005-04-08 |
| Summary: | summary |