The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Imx T4.
| Device ID | K925110 |
| 510k Number | K925110 |
| Device Name: | ABBOTT IMX T4 |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Carol M Cooper |
| Correspondent | Carol M Cooper ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-09 |
| Decision Date | 1993-01-26 |