The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Architect Shbg Reagent Kit, Architect Shbg Calibrator Kit, And Architect Shbg Control Kit With Models, 8k26-25, 8k26-01.
| Device ID | K060818 |
| 510k Number | K060818 |
| Device Name: | ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01 |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | BIOKIT S.A. CAN MALE S/N LLISSA D'AMUNT Barcelona, ES 08186 |
| Contact | Joan Guixer |
| Correspondent | Joan Guixer BIOKIT S.A. CAN MALE S/N LLISSA D'AMUNT Barcelona, ES 08186 |
| Product Code | CDZ |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-27 |
| Decision Date | 2007-01-23 |
| Summary: | summary |