The following data is part of a premarket notification filed by Wallac Oy with the FDA for Delfia(r) Hgh Kit.
| Device ID | K930484 |
| 510k Number | K930484 |
| Device Name: | DELFIA(R) HGH KIT |
| Classification | Radioimmunoassay, Human Growth Hormone |
| 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 | CFL |
| CFR Regulation Number | 862.1370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-29 |
| Decision Date | 1993-05-11 |