The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Onetouch Vita Blood Glucose Monitoring System.
| Device ID | K082513 |
| 510k Number | K082513 |
| Device Name: | ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Contact | Oyinkan Donaldson |
| Correspondent | Oyinkan Donaldson 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 | 2008-09-02 |
| Decision Date | 2008-10-22 |
| Summary: | summary |