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.
| Device ID | K193371 |
| 510k Number | K193371 |
| Device Name: | FreeStyle Libre 2 Flash Glucose Monitoring System |
| Classification | Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems |
| Applicant | Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502 |
| Contact | Naveen Thuramalla |
| Correspondent | Naveen Thuramalla Abbott Diabetes Care Inc. 1360 South Loop Road 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 | 2019-12-05 |
| Decision Date | 2020-06-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30357599804009 | K193371 | 000 |
| 30357599803002 | K193371 | 000 |
| 30357599801008 | K193371 | 000 |
| 30357599800001 | K193371 | 000 |
| 30357599805006 | K193371 | 000 |