The following data is part of a premarket notification filed by Diasorin Inc. with the FDA for Liaison Testosterone Xt.
| Device ID | K201908 |
| 510k Number | K201908 |
| Device Name: | LIAISON Testosterone Xt |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 |
| Contact | John Walter |
| Correspondent | Mari Meyer DiaSorin Inc. 1951 Northwestern Avenue Stillwater, MN 55082 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-09 |
| Decision Date | 2020-10-15 |