The following data is part of a premarket notification filed by Wallac Oy with the FDA for Modification To: Autodelfia Neonatal 17a-oh-progesterone L Kit.
| Device ID | K050960 |
| 510k Number | K050960 |
| Device Name: | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT |
| Classification | Radioimmunoassay, 17-hydroxyprogesterone |
| Applicant | WALLAC OY MUSTIONKATU 6 Turku, FI 20750 |
| Contact | Gunnel Laaksonen |
| Correspondent | Gunnel Laaksonen WALLAC OY MUSTIONKATU 6 Turku, FI 20750 |
| Product Code | JLX |
| CFR Regulation Number | 862.1395 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-18 |
| Decision Date | 2005-07-11 |
| Summary: | summary |