The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Freestyle Precision Pro Blood Glucose And B-ketone Monitoring System.
| Device ID | K132511 |
| 510k Number | K132511 |
| Device Name: | FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Contact | Vrusahli Tembe |
| Correspondent | Vrusahli Tembe ABBOTT DIABETES CARE INC. 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2013-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00093815714125 | K132511 | 000 |
| 00093815714118 | K132511 | 000 |
| 30093815712887 | K132511 | 000 |
| 30093815712849 | K132511 | 000 |
| 00357599815004 | K132511 | 000 |