FDA Product Code
FDA Product Code NRI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5090
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K061842 | QUANTA LITE PBC SCREEN IGG/IGA ELISA | Inova Diagnostics, Inc. | 2006-10-18 | Traditional | PDF ↗ |
| K040885 | QUANTA LITE GP210 ELISA | Inova Diagnostics, Inc. | 2004-06-25 | Traditional | PDF ↗ |
Product code NRI · Class II · Immunology. Data: openFDA.