The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Onetouch Reveal Diabetes Management Application.
| Device ID | K120558 |
| 510k Number | K120558 |
| Device Name: | ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | LIFESCAN, INC. 200 LAWRENCE DRIVE MAILSTOP C-2-2 West Chester, PA 19380 |
| Contact | Andrea Tasker |
| Correspondent | Andrea Tasker LIFESCAN, INC. 200 LAWRENCE DRIVE MAILSTOP C-2-2 West Chester, PA 19380 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-24 |
| Decision Date | 2013-02-07 |
| Summary: | summary |