The following data is part of a premarket notification filed by Roche Diabetes Care with the FDA for Accu-chek Guide Me Blood Glucose Monitoring System.
| Device ID | K181131 |
| 510k Number | K181131 |
| Device Name: | Accu-Chek Guide Me Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Roche Diabetes Care 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Ginger Emrich |
| Correspondent | Ginger Emrich Roche Diabetes Care 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 | 2018-04-30 |
| Decision Date | 2018-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10365702733104 | K181131 | 000 |
| 10365702732107 | K181131 | 000 |
| 00365702731103 | K181131 | 000 |
| 10365702730103 | K181131 | 000 |
| 00365702702431 | K181131 | 000 |