The following data is part of a premarket notification filed by Wallac Oy with the FDA for Delfia Digoxin Kit.
| Device ID | K924594 |
| 510k Number | K924594 |
| Device Name: | DELFIA DIGOXIN KIT |
| Classification | Enzyme Immunoassay, Digoxin |
| 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 | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-10 |
| Decision Date | 1992-12-17 |