The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Accu-chek Aviva Plus Blood Glucose Monitoring System.
| Device ID | K101299 |
| 510k Number | K101299 |
| Device Name: | ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Andrene Heron |
| Correspondent | Andrene Heron Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | LFR |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-10 |
| Decision Date | 2011-09-21 |
| Summary: | summary |