The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Tracker Diabetes Management System.
| Device ID | K020866 |
| 510k Number | K020866 |
| Device Name: | FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 -7000 |
| Contact | Donna K Templeman |
| Correspondent | Donna K Templeman ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 -7000 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-18 |
| Decision Date | 2002-06-11 |
| Summary: | summary |