The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Testok-125.
| Device ID | K800776 |
| 510k Number | K800776 |
| Device Name: | TESTOK-125 |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | SORIN BIOMEDICA, FIAT, USA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-07 |
| Decision Date | 1980-04-21 |