The following data is part of a premarket notification filed by Abbott Diabetes Care Inc with the FDA for Freestyle Precision Neo Blood Glucose Monitoring System.
| Device ID | K142928 |
| 510k Number | K142928 |
| Device Name: | FreeStyle Precision Neo Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT DIABETES CARE INC 1360 SOUTH LOOP ROAD Alameda, CA 94502 |
| Contact | Michelle Ricafort |
| Correspondent | Michelle Ricafort ABBOTT DIABETES CARE INC 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 | 2014-10-09 |
| Decision Date | 2015-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30357599000302 | K142928 | 000 |
| 30093815751756 | K142928 | 000 |
| 30093815715819 | K142928 | 000 |
| 30093815715796 | K142928 | 000 |
| 30093815715772 | K142928 | 000 |