The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Architect Total T4 Calibrators.
| Device ID | K151566 |
| 510k Number | K151566 |
| Device Name: | Abbott ARCHITECT Total T4 Calibrators |
| Classification | Calibrator, Secondary |
| Applicant | ABBOTT LABORATORIES 100 Abbott Park Road Dept. 09VA, AP08 Abbott Park, IL 60064 |
| Contact | Lisa Lukowski |
| Correspondent | Lisa Lukowski ABBOTT LABORATORIES 100 Abbott Park Road Dept. 09VA, AP08 Abbott Park, IL 60064 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-10 |
| Decision Date | 2015-07-10 |
| Summary: | summary |