The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Precision Neo H Blood Glucose Monitoring System.
| Device ID | K153330 |
| 510k Number | K153330 |
| Device Name: | FreeStyle Precision Neo H Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94202 |
| Contact | Arul Sterlin |
| Correspondent | Arul Sterlin Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94202 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-19 |
| Decision Date | 2016-02-19 |
| Summary: | summary |