The following data is part of a premarket notification filed by Inverness Medical Innovations, Inc. with the FDA for Induo Blood Glucose Meter.
| Device ID | K011616 |
| 510k Number | K011616 |
| Device Name: | INDUO BLOOD GLUCOSE METER |
| Classification | System, Test, Blood Glucose, Over The Counter |
| 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 | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | FMF |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-25 |
| Decision Date | 2001-06-21 |
| Summary: | summary |