The following data is part of a premarket notification filed by Wallac Oy with the FDA for Autodelfia Neonatal 17a-oh-progesterone Kit.
| Device ID | K081922 |
| 510k Number | K081922 |
| Device Name: | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT |
| Classification | Radioimmunoassay, 17-hydroxyprogesterone |
| Applicant | WALLAC OY MUSTIONKATU 6 Turku, FI 20750 |
| Contact | Katriina Suonpaa |
| Correspondent | Katriina Suonpaa WALLAC OY MUSTIONKATU 6 Turku, FI 20750 |
| Product Code | JLX |
| CFR Regulation Number | 862.1395 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-07 |
| Decision Date | 2009-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147292523 | K081922 | 000 |
| 06438147292486 | K081922 | 000 |
| 06438147292479 | K081922 | 000 |