The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, And 16005.
| Device ID | K031260 |
| 510k Number | K031260 |
| Device Name: | FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 |
| 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 |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-21 |
| Decision Date | 2003-12-19 |
| Summary: | summary |