The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Freestyle Auto-assist Software Verson 2.0 With Model Prt24238-001.
| Device ID | K123089 |
| 510k Number | K123089 |
| Device Name: | FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ABBOTT LABORATORIES 1360 SOUTH LOOP ROAD Alameda, CA 94502 |
| Contact | David G Lambert |
| Correspondent | David G Lambert ABBOTT LABORATORIES 1360 SOUTH LOOP ROAD Alameda, CA 94502 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-01 |
| Decision Date | 2013-04-05 |
| Summary: | summary |