The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Onetouch Ultra 2 Blood Glucose Monitoring System.
| Device ID | K053529 |
| 510k Number | K053529 |
| Device Name: | ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Contact | Lisa Mcgrath |
| Correspondent | Lisa Mcgrath LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-19 |
| Decision Date | 2006-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20353885010515 | K053529 | 000 |
| 20353885010010 | K053529 | 000 |
| 20353885008857 | K053529 | 000 |
| 20353885008376 | K053529 | 000 |
| 20353885000271 | K053529 | 000 |
| 20353885011857 | K053529 | 000 |