The following data is part of a premarket notification filed by Roche Diagnostics Corporation with the FDA for Accu-chek Aviva Expert System.
| Device ID | K142089 |
| 510k Number | K142089 |
| Device Name: | ACCU-CHEK AVIVA EXPERT SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | ROCHE DIAGNOSTICS CORPORATION 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Greg Mondics |
| Correspondent | Nathan A. Carrington ROCHE DIAGNOSTICS CORPORATION 9115 Hague Road 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 | 2014-08-01 |
| Decision Date | 2014-12-17 |
| Summary: | summary |