The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Direct Estriol Ria Kit.
| Device ID | K781546 |
| 510k Number | K781546 |
| Device Name: | DIRECT ESTRIOL RIA KIT |
| Classification | Radioimmunoassay, Estriol |
| Applicant | Immunalysis Corporation 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CGI |
| CFR Regulation Number | 862.1265 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-13 |
| Decision Date | 1978-12-04 |