The following data is part of a premarket notification filed by Radioassay Systems Laboratories, Inc. with the FDA for Hydroxyprogesterone By Ria 17a.
| Device ID | K840886 |
| 510k Number | K840886 |
| Device Name: | HYDROXYPROGESTERONE BY RIA 17A |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | RADIOASSAY SYSTEMS LABORATORIES, INC. CA |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-27 |
| Decision Date | 1984-04-18 |