The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Accu-check Combo System.
| Device ID | K111353 |
| 510k Number | K111353 |
| Device Name: | ACCU-CHECK COMBO SYSTEM |
| Classification | Pump, Infusion, Insulin |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Scott Thiel |
| Correspondent | Scott Thiel Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | LZG |
| Subsequent Product Code | NBW |
| Subsequent Product Code | NDC |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-16 |
| Decision Date | 2012-07-17 |
| Summary: | summary |