The following data is part of a premarket notification filed by Roche Diabetes Care, Inc. with the FDA for Accu-chek Guide Blood Glucose Monitoring System.
| Device ID | K160944 |
| 510k Number | K160944 |
| Device Name: | ACCU-CHEK Guide Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Roche Diabetes Care, Inc. 9115 Hague Road Indianapolis, IN 46250 -0457 |
| Contact | Khone Saysana |
| Correspondent | Khone Saysana Roche Diabetes Care, Inc. 9115 Hague Road Indianapolis, IN 46250 -0457 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-05 |
| Decision Date | 2016-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00365702729100 | K160944 | 000 |
| 00365702701908 | K160944 | 000 |
| 00365702701953 | K160944 | 000 |
| 00365702701977 | K160944 | 000 |
| 10365702702032 | K160944 | 000 |
| 00365702702042 | K160944 | 000 |
| 00365702702066 | K160944 | 000 |
| 00365702710108 | K160944 | 000 |
| 00365702712102 | K160944 | 000 |
| 00365702719101 | K160944 | 000 |
| 10365702726106 | K160944 | 000 |
| 10365702728100 | K160944 | 000 |
| 00365702609105 | K160944 | 000 |