The following data is part of a premarket notification filed by Wallac Oy with the FDA for Delfia Shbg Kit.
| Device ID | K940449 |
| 510k Number | K940449 |
| Device Name: | DELFIA SHBG KIT |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | WALLAC OY P.O. BOX 10 SF-20101 TURKU Finland, FI |
| Contact | Gunnel Laaksonen |
| Correspondent | Gunnel Laaksonen WALLAC OY P.O. BOX 10 SF-20101 TURKU Finland, FI |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-01 |
| Decision Date | 1994-09-06 |