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, Test Strips (50ct), Test Strips (100ct).
| Device ID | K140371 |
| 510k Number | K140371 |
| Device Name: | FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT), TEST STRIPS (100CT) |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-14 |
| Decision Date | 2014-09-30 |
| Summary: | summary |