The following data is part of a premarket notification filed by Wallac Oy with the FDA for Auto Delfia.
| Device ID | K935047 |
| 510k Number | K935047 |
| Device Name: | AUTO DELFIA |
| Classification | Fluorometer, For Clinical Use |
| Applicant | WALLAC OY P.O. BOX 10 SF-20101 TURKU Finland, FI |
| Contact | Gunnell Laaksonen |
| Correspondent | Gunnell Laaksonen WALLAC OY P.O. BOX 10 SF-20101 TURKU Finland, FI |
| Product Code | KHO |
| CFR Regulation Number | 862.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-21 |
| Decision Date | 1994-05-23 |