FDA Product Code
FDA Product Code PJI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5930
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K203035 | Eonis SCID-SMA kit | Perkinelmer, Inc. | 2022-11-09 | Traditional | PDF ↗ |
| DEN140010 | PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM | Wallac OY | 2014-12-15 | Direct | — |
Product code PJI · Class II · Immunology. Data: openFDA.