The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Human Chorionic Gonadatrophin And Uncon. Estriol.
| Device ID | K920826 |
| 510k Number | K920826 |
| Device Name: | HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| 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 | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-24 |
| Decision Date | 1992-04-07 |