The following data is part of a premarket notification filed by Wallac Oy with the FDA for Autodelfia Unconjugated Estriol (ue3) Kit.
| Device ID | K944490 |
| 510k Number | K944490 |
| Device Name: | AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT |
| Classification | Radioimmunoassay, Estriol |
| Applicant | WALLAC OY MUSTIONKATU 6 Turku, FI 20750 |
| Contact | Gunnel Laaksonen |
| Correspondent | Gunnel Laaksonen WALLAC OY MUSTIONKATU 6 Turku, FI 20750 |
| Product Code | CGI |
| CFR Regulation Number | 862.1265 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-13 |
| Decision Date | 1994-12-09 |