The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Insulinx Blood Glucose Monitoring System.
| Device ID | K120568 |
| 510k Number | K120568 |
| Device Name: | FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Contact | Arul Sterlin |
| Correspondent | Arul Sterlin ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-27 |
| Decision Date | 2012-03-29 |
| Summary: | summary |