FDA Product Code
FDA Product Code PNI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5665
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K161951 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay | Kronus, Inc. | 2016-07-22 | Special | PDF ↗ |
| DEN150030 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay | Kronus, Inc. | 2016-04-25 | Direct | — |
Product code PNI · Class II · Immunology. Data: openFDA.