The following data is part of a premarket notification filed by Wien Laboratories, Inc. with the FDA for Shbg.
| Device ID | K912850 |
| 510k Number | K912850 |
| Device Name: | SHBG |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | WIEN LABORATORIES, INC. P.O. BOX 227 Succasunna, NJ 07876 |
| Contact | Bret G Wien |
| Correspondent | Bret G Wien WIEN LABORATORIES, INC. P.O. BOX 227 Succasunna, NJ 07876 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-28 |
| Decision Date | 1991-08-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SHBG 73572060 1436967 Dead/Cancelled |
FARMOS-YHTYMA OY 1985-12-06 |