The following data is part of a premarket notification filed by Wallac Oy with the FDA for Delfia Htsh Ultra Kit.
| Device ID | K923401 |
| 510k Number | K923401 |
| Device Name: | DELFIA HTSH ULTRA KIT |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | WALLAC OY P.O. BOX 10 SF-20101 TURKU Finland, FI |
| Contact | Gennel Laaksonen |
| Correspondent | Gennel Laaksonen WALLAC OY P.O. BOX 10 SF-20101 TURKU Finland, FI |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-10 |
| Decision Date | 1992-11-30 |