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 |