The following data is part of a premarket notification filed by Diagnostics Biochem Canada, Inc. with the FDA for Androstenedione Radioimmunoassay Kit.
| Device ID | K801729 |
| 510k Number | K801729 |
| Device Name: | ANDROSTENEDIONE RADIOIMMUNOASSAY KIT |
| Classification | Radioimmunoassay, Androstenedione |
| Applicant | DIAGNOSTICS BIOCHEM CANADA, 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 | 1980-07-24 |
| Decision Date | 1980-10-31 |