The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Ft4 Liaison Control Thyroid 1 Liaison Control Thyroid 2 Liaison Control Thyroid 3.
| Device ID | K121951 |
| 510k Number | K121951 |
| Device Name: | LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Contact | Kelly R Sauer |
| Correspondent | Kelly R Sauer DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-03 |
| Decision Date | 2013-04-04 |
| Summary: | summary |