The following data is part of a premarket notification filed by Abbott Diabetes Care Inc. with the FDA for Precision Xceed Pro Blood Glucose And B-ketone Monitoring System With Models Bgms:70900-03, 70090-02, G3ch Strips.
| Device ID | K080960 |
| 510k Number | K080960 |
| Device Name: | PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Contact | Tammy Wharton |
| Correspondent | Tammy Wharton ABBOTT DIABETES CARE INC. 1360 SOUTH LOOP RD. Alameda, CA 94502 |
| Product Code | NBW |
| Subsequent Product Code | JIN |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-03 |
| Decision Date | 2008-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00357599000257 | K080960 | 000 |
| 00357599000189 | K080960 | 000 |
| 00357599000158 | K080960 | 000 |
| 00357599000134 | K080960 | 000 |
| 35021791709350 | K080960 | 000 |
| 30093815709320 | K080960 | 000 |