The following data is part of a premarket notification filed by Roche Diagnostics Operations Inc with the FDA for Accu-chek Aviva Expert Blood Glucose Monitoring System.
| Device ID | K131366 |
| 510k Number | K131366 |
| Device Name: | ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | ROCHE DIAGNOSTICS OPERATIONS INC 9115 HAGUE RD Indianapolis, IN 46250 |
| Contact | Nathan Carrington |
| Correspondent | Nathan Carrington ROCHE DIAGNOSTICS OPERATIONS INC 9115 HAGUE RD Indianapolis, IN 46250 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-13 |
| Decision Date | 2013-10-11 |
| Summary: | summary |