The following data is part of a premarket notification filed by Abbott Laboratories Inc with the FDA for Precision Xtra Plus Or Optium Plus, Blood Glucose Test Strips.
| Device ID | K051213 |
| 510k Number | K051213 |
| Device Name: | PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT LABORATORIES INC 1360 SOUTH LOOP ROAD Alameda, CA 94502 |
| Contact | Andrea Ruth |
| Correspondent | Andrea Ruth ABBOTT LABORATORIES INC 1360 SOUTH LOOP ROAD Alameda, CA 94502 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-12 |
| Decision Date | 2005-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30093815998786 | K051213 | 000 |
| 30093815998779 | K051213 | 000 |
| 30093815998380 | K051213 | 000 |
| 40093815997281 | K051213 | 000 |
| 30093815996959 | K051213 | 000 |
| 30093815996942 | K051213 | 000 |
| 30093815800508 | K051213 | 000 |