The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Freestyle Lite Blood Glucose Monitoring System.
| Device ID | K150332 |
| 510k Number | K150332 |
| Device Name: | FreeStyle Lite Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT LABORATORIES 1360 South Loop Road Alameda, CA 94502 |
| Contact | Sai Sriharshada Tatavarty |
| Correspondent | Ms. 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 | 2015-02-10 |
| Decision Date | 2015-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30699073715013 | K150332 | 000 |
| 40699073708050 | K150332 | 000 |
| 30699073708046 | K150332 | 000 |
| 30699073000010 | K150332 | 000 |
| 00093815708292 | K150332 | 000 |