The following data is part of a premarket notification filed by Wallac Oy with the FDA for Delfia Neonatal Irt Kit, Model A005-110.
| Device ID | K003664 |
| 510k Number | K003664 |
| Device Name: | DELFIA NEONATAL IRT KIT, MODEL A005-110 |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | WALLAC OY MUSTIONKATU 6 Turku, FI 20750 |
| Contact | Gunnel Laaksonen |
| Correspondent | Gunnel Laaksonen WALLAC OY MUSTIONKATU 6 Turku, FI 20750 |
| Product Code | CGZ |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-28 |
| Decision Date | 2001-02-14 |