The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Freestyle Insulinx Blood Glucose Monitoring Systems.
| Device ID | K111874 |
| 510k Number | K111874 |
| Device Name: | FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS |
| Classification | Glucose Dehydrogenase, Glucose |
| Applicant | ABBOTT LABORATORIES 1360 SOUTH LOOP ROAD Alameda, CA 94502 |
| Contact | Arul Sterlin |
| Correspondent | Arul Sterlin ABBOTT LABORATORIES 1360 SOUTH LOOP ROAD Alameda, CA 94502 |
| Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-01 |
| Decision Date | 2012-02-16 |
| Summary: | summary |