The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Amerlex-m High Sensitivity Unconjugated Estriol.
| Device ID | K920576 |
| 510k Number | K920576 |
| Device Name: | AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL |
| Classification | Radioimmunoassay, Estriol |
| Applicant | EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Contact | Yvonne Adair |
| Correspondent | Yvonne Adair EASTMAN KODAK COMPANY 343 STATE ST. Rochester, NY 14650 |
| Product Code | CGI |
| CFR Regulation Number | 862.1265 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-10 |
| Decision Date | 1992-03-23 |