The following data is part of a premarket notification filed by Wallac Oy with the FDA for Delfia Neonatal Thyroxine Kit.
| Device ID | K943416 |
| 510k Number | K943416 |
| Device Name: | DELFIA NEONATAL THYROXINE KIT |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | WALLAC OY P.O. BOX 10 SF-20101 TURKU Finland, FI |
| Contact | Gunnel Laadsonen |
| Correspondent | Gunnel Laadsonen WALLAC OY P.O. BOX 10 SF-20101 TURKU Finland, FI |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-15 |
| Decision Date | 1995-03-10 |