The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Architect Free T3.
| Device ID | K170160 |
| 510k Number | K170160 |
| Device Name: | Abbott ARCHITECT Free T3 |
| Classification | Calibrator, Secondary |
| 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 | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-18 |
| Decision Date | 2017-02-15 |
| Summary: | summary |