The following data is part of a premarket notification filed by Cilag Gmbh International with the FDA for Onetouch Verio Blood Glucose Monitoring System.
| Device ID | K131363 |
| 510k Number | K131363 |
| Device Name: | ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | CILAG GMBH INTERNATIONAL GUBELSTRASSE 34 Zug, CH 6300 |
| Contact | Oyinkan Donaldson |
| Correspondent | Oyinkan Donaldson CILAG GMBH INTERNATIONAL GUBELSTRASSE 34 Zug, CH 6300 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-13 |
| Decision Date | 2013-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20353885008734 | K131363 | 000 |
| 20353885008727 | K131363 | 000 |
| 20353885008710 | K131363 | 000 |
| 20353885011819 | K131363 | 000 |
| 20353885011802 | K131363 | 000 |