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 |