The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Relion Ultima Advance Blood Glucose Monitoring System Models, Bgms 71030-01 Strips: 7103-01 (20 Count).
| Device ID | K081975 |
| 510k Number | K081975 |
| Device Name: | RELION ULTIMA ADVANCE BLOOD GLUCOSE MONITORING SYSTEM MODELS, BGMS 71030-01 STRIPS: 7103-01 (20 COUNT) |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Contact | Arul Sterlin |
| Correspondent | Arul Sterlin ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-11 |
| Decision Date | 2008-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30093815710654 | K081975 | 000 |
| 30093815710425 | K081975 | 000 |
| 30093815710418 | K081975 | 000 |