The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Architect Free T4.
| Device ID | K123379 |
| 510k Number | K123379 |
| Device Name: | ABBOTT ARCHITECT FREE T4 |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Jacek Gorzowski |
| Correspondent | Jacek Gorzowski ABBOTT LABORATORIES 100 ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | CEC |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-01 |
| Decision Date | 2012-11-27 |
| Summary: | summary |