The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Precision Neo Blood Glucose Test Strips.
| Device ID | K171941 |
| 510k Number | K171941 |
| Device Name: | FreeStyle Precision Neo Blood Glucose Test Strips |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502 |
| Contact | Danielle Tayor |
| Correspondent | Stephanie Yun Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-28 |
| Decision Date | 2017-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30357599000357 | K171941 | 000 |
| 30357599000340 | K171941 | 000 |
| 30357599000333 | K171941 | 000 |