The following data is part of a premarket notification filed by Roche Diagnostics Operations Inc with the FDA for Accu-chek Aviva Plus Test Strip.
| Device ID | K131029 |
| 510k Number | K131029 |
| Device Name: | ACCU-CHEK AVIVA PLUS TEST STRIP |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ROCHE DIAGNOSTICS OPERATIONS INC 9115 HAGUE RD Indianapolis, IN 46250 |
| Contact | Khone Saysana |
| Correspondent | Khone Saysana ROCHE DIAGNOSTICS OPERATIONS INC 9115 HAGUE RD Indianapolis, IN 46250 |
| Product Code | NBW |
| Subsequent Product Code | LFR |
| Subsequent Product Code | LZG |
| Subsequent Product Code | NDC |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-12 |
| Decision Date | 2013-08-09 |
| Summary: | summary |