The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Accu-chek Aviva Connect Blood Glucose Monitoring System.
| Device ID | K141867 |
| 510k Number | K141867 |
| Device Name: | ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Khone Saysana |
| Correspondent | Khone Saysana Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-10 |
| Decision Date | 2015-03-03 |
| Summary: | summary |