The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Freestyle Freedom Blood Glucose Monitoring Sytem.
| Device ID | K152442 |
| 510k Number | K152442 |
| Device Name: | Freestyle Freedom Blood Glucose Monitoring Sytem |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT LABORATORIES 1360 South Loop Road Alameda, CA 94502 |
| Contact | Sai Sriharshada Tatavarty |
| Correspondent | Sai Sriharshada Tatavarty ABBOTT LABORATORIES 1360 South Loop Road 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 | 2015-08-27 |
| Decision Date | 2015-12-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30699073110047 | K152442 | 000 |