The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for One Touch Profile Complete Diabetes Tracking System.
| Device ID | K950727 |
| 510k Number | K950727 |
| Device Name: | ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Contact | Judy Martin |
| Correspondent | Judy Martin LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-16 |
| Decision Date | 1995-06-01 |