The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for One Touch Ultrasmart Blood Glucose Monitoring System.
| Device ID | K021819 |
| 510k Number | K021819 |
| Device Name: | ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Contact | Mary Ellen Holden |
| Correspondent | Mary Ellen Holden LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-04 |
| Decision Date | 2002-08-23 |
| Summary: | summary |