FDA Product Code
FDA Product Code QUE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5980
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262893 | Eonis SMA kit | Revvity, Inc. | 2026-09-30 | Traditional | PDF ↗ |
| DEN200044 | Eonis SCID-SMA Kit | Perkinelmer, Inc. | 2022-11-09 | Direct | — |
Product code QUE · Class II · Immunology. Data: openFDA.