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 |