The following data is part of a premarket notification filed by Diagnostics Biochem Canada, Inc. with the FDA for Hydroxyprogesterone-17.
| Device ID | K832297 |
| 510k Number | K832297 |
| Device Name: | HYDROXYPROGESTERONE-17 |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | DIAGNOSTICS BIOCHEM CANADA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-13 |
| Decision Date | 1983-09-01 |