The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Modification To Precision Xtra Advanced Diabetes Management System.
| Device ID | K040814 |
| 510k Number | K040814 |
| Device Name: | MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT LABORATORIES 4-A CROSBY DR. Bedford, MA 01730 -1402 |
| Contact | Tracey H Wielinski |
| Correspondent | Tracey H Wielinski ABBOTT LABORATORIES 4-A CROSBY DR. Bedford, MA 01730 -1402 |
| Product Code | NBW |
| Subsequent Product Code | JIN |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-30 |
| Decision Date | 2004-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30093815998373 | K040814 | 000 |
| 30093815988145 | K040814 | 000 |
| 30093815715024 | K040814 | 000 |