The following data is part of a premarket notification filed by Cilag Gmbh International with the FDA for Onetouch Verio (tm) Iq Blood Glucose Monitoring System.
| Device ID | K110637 |
| 510k Number | K110637 |
| Device Name: | ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | CILAG GMBH INTERNATIONAL LANDIS AND GYR STRASSE 1 Zug, CH 6300 |
| Contact | Fiona Leeper |
| Correspondent | Fiona Leeper CILAG GMBH INTERNATIONAL LANDIS AND GYR STRASSE 1 Zug, CH 6300 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-04 |
| Decision Date | 2011-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20353885011550 | K110637 | 000 |
| 20353885012038 | K110637 | 000 |
| 20353885007706 | K110637 | 000 |
| 20353885007713 | K110637 | 000 |
| 20353885007720 | K110637 | 000 |
| 20353885007737 | K110637 | 000 |
| 20353885008406 | K110637 | 000 |
| 20353885009755 | K110637 | 000 |
| 20353885009762 | K110637 | 000 |
| 20353885010034 | K110637 | 000 |
| 20353885010485 | K110637 | 000 |
| 20353885012427 | K110637 | 000 |