The following data is part of a premarket notification filed by Lifescan Europe with the FDA for Onetouch Ultra Plus Flex Blood Glucose Monitoring System.
| Device ID | K151611 |
| 510k Number | K151611 |
| Device Name: | OneTouch Ultra Plus Flex Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | LIFESCAN EUROPE GUBELSTRASSE 34 Zug, CH Ch-6300 |
| Contact | Niki Skelly |
| Correspondent | Niki Skelly LIFESCAN SCOTLAND LTD BEECHWOOD PARK NORTH Inverness, Scotland, GB Iv2 3ed |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-15 |
| Decision Date | 2015-12-14 |
| Summary: | summary |