The following data is part of a premarket notification filed by Wallac Oy with the FDA for Gsp Neonatal 17a-oh-progesterone Kit Model: 3305-001u.
| Device ID | K100682 |
| 510k Number | K100682 |
| Device Name: | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U |
| Classification | Radioimmunoassay, 17-hydroxyprogesterone |
| Applicant | WALLAC OY 8275 CARLOWAY ROAD Indianapolis, IN 46236 |
| Contact | Kay Taylor |
| Correspondent | Kay Taylor WALLAC OY 8275 CARLOWAY ROAD Indianapolis, IN 46236 |
| Product Code | JLX |
| CFR Regulation Number | 862.1395 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-10 |
| Decision Date | 2010-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438147321209 | K100682 | 000 |