FDA Product Code
FDA Product Code PZH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5130
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K211115 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | 2021-05-13 | Special | PDF ↗ |
| K192858 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | 2019-11-05 | Special | PDF ↗ |
| K171868 | A1AT Genotyping Test | Progenika Biopharma S.A., A Grifols Company | 2017-11-11 | Traditional | PDF ↗ |
Product code PZH · Class II · Immunology. Data: openFDA.