The following data is part of a premarket notification filed by Roche Diagnostics Corporation with the FDA for Accu-chek Aviva Plus System.
| Device ID | K133862 |
| 510k Number | K133862 |
| Device Name: | ACCU-CHEK AVIVA PLUS SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ROCHE DIAGNOSTICS CORPORATION 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Khone Saysana |
| Correspondent | Khone Saysana ROCHE DIAGNOSTICS CORPORATION 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 | 2013-12-19 |
| Decision Date | 2014-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00365702725102 | K133862 | 000 |
| 10365702724102 | K133862 | 000 |
| 00365702723108 | K133862 | 000 |
| 00365702702394 | K133862 | 000 |