The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Onetouch Profile Blood Glucose Monitoring System.
| Device ID | K021943 |
| 510k Number | K021943 |
| Device Name: | ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Contact | John E Hughes |
| Correspondent | John E Hughes 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 | 2002-05-28 |
| Decision Date | 2002-06-28 |
| Summary: | summary |