Wallac Oy, A Subsidiary of Perkinelmer, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K173829 | NeoLSD MSMS kit | July 18, 2018 |
| K133652 | GSP NEONATAL TOTAL GALACTOSE KIT | April 28, 2014 |
| K110274 | AUTODELFIA NEONATAL IRT KIT | June 10, 2011 |
| K103484 | GSP NEONATAL THYROXINE (T4) | April 22, 2011 |