The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Accu-chek Compact Plus Blood Glucose Monitoring System.
| Device ID | K081389 |
| 510k Number | K081389 |
| Device Name: | ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46256 |
| Contact | Scott Thiel |
| Correspondent | Scott Thiel Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46256 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-19 |
| Decision Date | 2008-07-15 |
| Summary: | summary |