The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Libre 2 Flash Glucose Monitoring System (with Freestyle Libre 2 App).
| Device ID | K210943 |
| 510k Number | K210943 |
| Device Name: | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) |
| Classification | Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems |
| Applicant | Abbott Diabetes Care Inc. 1360 South Loop Rd. Alameda, CA 94502 |
| Contact | Ono Bacani |
| Correspondent | Ono Bacani Abbott Diabetes Care Inc. 1360 South Loop Rd. Alameda, CA 94502 |
| Product Code | QLG |
| CFR Regulation Number | 862.1355 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-30 |
| Decision Date | 2021-11-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00357599809003 | K210943 | 000 |