The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Free-style Freedom Blood Glucose Monitoring System, Model 11001.
| Device ID | K051839 |
| 510k Number | K051839 |
| Device Name: | FREE-STYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM, MODEL 11001 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Contact | Dhruma Shah |
| Correspondent | Dhruma Shah ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-07 |
| Decision Date | 2006-03-09 |
| Summary: | summary |