The following data is part of a premarket notification filed by Diasorin, Inc. with the FDA for Liaison Testosterone; Liaison Testosterone Control Set.
| Device ID | K122793 |
| 510k Number | K122793 |
| Device Name: | LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Contact | John Eskdale |
| Correspondent | John Eskdale DIASORIN, INC. 1951 NORTHWESTERN AVE. Stillwater, MN 55082 -0285 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-12 |
| Decision Date | 2013-01-25 |
| Summary: | summary |