The following data is part of a premarket notification filed by Biokit, S.a. with the FDA for Architect Shbg.
| Device ID | K152185 |
| 510k Number | K152185 |
| Device Name: | ARCHITECT SHBG |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | BIOKIT, S.A. CAN MALE, S/N Llica D Amunt, ES 08186 |
| Contact | Angels Roma |
| Correspondent | Angels Roma BIOKIT, S.A. CAN MALE, S/N Llica D Amunt, ES 08186 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-05 |
| Decision Date | 2016-02-11 |
| Summary: | summary |