The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Glucose Test System.
| Device ID | K113137 |
| 510k Number | K113137 |
| Device Name: | GLUCOSE TEST SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Contact | Khonesavanh Saysana |
| Correspondent | Khonesavanh Saysana Roche Diagnostics 9115 HAGUE ROAD Indianapolis, IN 46250 -0416 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-24 |
| Decision Date | 2012-01-06 |
| Summary: | summary |