The following data is part of a premarket notification filed by Wien Laboratories, Inc. with the FDA for Dhea Test Set.
| Device ID | K771793 |
| 510k Number | K771793 |
| Device Name: | DHEA TEST SET |
| Classification | Radioimmunoassay, Androsterone |
| Applicant | WIEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIY |
| CFR Regulation Number | 862.1080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-09-22 |
| Decision Date | 1977-11-02 |