The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for One Touch Ultra And One Touch Induo Blood Glucose Monitoring Systems.
| Device ID | K024194 |
| 510k Number | K024194 |
| Device Name: | ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMS |
| 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 | 2002-12-20 |
| Decision Date | 2003-02-07 |
| Summary: | summary |