The following data is part of a premarket notification filed by Abbott Diabetes Care with the FDA for Freestyle Precision Pro Blood Glucose And B-ketone Monitoring System.
| Device ID | K130094 |
| 510k Number | K130094 |
| Device Name: | FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT DIABETES CARE 1360 SOUTH LOOP RD Alameda, CA 94502 |
| Contact | David G Lambert |
| Correspondent | David G Lambert ABBOTT DIABETES CARE 1360 SOUTH LOOP RD Alameda, CA 94502 |
| Product Code | NBW |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JQP |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-10 |
| Decision Date | 2013-06-27 |
| Summary: | summary |