The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Architect Free T4.
| Device ID | K173122 |
| 510k Number | K173122 |
| Device Name: | Abbott Architect Free T4 |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | Abbott Laboratories 100 Abbott Park Road Dept. 09AA, Bldg, AP08 Abbott Park, IL 60064 |
| Contact | Linda Sohn |
| Correspondent | Linda Sohn Abbott Laboratories 100 Abbott Park Road Dept. 09AA, Bldg, AP08 Abbott Park, IL 60064 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-10-27 |
| Summary: | summary |