The following data is part of a premarket notification filed by Nordiclab Intl. with the FDA for Nordiclab Progesterone Ria Test.
| Device ID | K800922 |
| 510k Number | K800922 |
| Device Name: | NORDICLAB PROGESTERONE RIA TEST |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | NORDICLAB INTL. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-21 |
| Decision Date | 1980-05-14 |