FDA Product Code
FDA Product Code OIF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5660
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K220085 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | Kronus, Inc. | 2023-08-24 | Traditional | PDF ↗ |
| K171731 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | Kronus, Inc. | 2018-01-19 | Traditional | PDF ↗ |
| K073590 | KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT | Kronus Market Development Associates, Inc. | 2008-04-10 | Traditional | PDF ↗ |
Product code OIF · Class II · Immunology. Data: openFDA.