The following data is part of a premarket notification filed by Inverness Medical Innovations, Inc. with the FDA for One Touch Fasttake Compact Blood Glucose Monitoring System, One Touch Ultra Blood Glucose Monitoring System.
| Device ID | K011479 |
| 510k Number | K011479 |
| Device Name: | ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | INVERNESS MEDICAL INNOVATIONS, INC. 51 SAWYER RD., SUITE 200 Waltham, MA 02453 -3448 |
| Contact | Carol A Adiletto |
| Correspondent | Carol A Adiletto INVERNESS MEDICAL INNOVATIONS, INC. 51 SAWYER RD., SUITE 200 Waltham, MA 02453 -3448 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-14 |
| Decision Date | 2001-11-30 |