The following data is part of a premarket notification filed by Wien Laboratories, Inc. with the FDA for Androstenedione Test Set 125i.
| Device ID | K832452 |
| 510k Number | K832452 |
| Device Name: | ANDROSTENEDIONE TEST SET 125I |
| Classification | Radioimmunoassay, Androstenedione |
| Applicant | WIEN LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CIZ |
| CFR Regulation Number | 862.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-25 |
| Decision Date | 1983-09-12 |