FDA Product Code
FDA Product Code OVK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.6010
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | 2025-12-16 | Traditional | PDF ↗ |
| K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | Roche Diagnostics | 2016-12-14 | Traditional | PDF ↗ |
| K100831 | CYFRA 21-1 EIA MODEL 211-10 | Fujirebio Diagnostics,Inc. | 2011-05-26 | Traditional | PDF ↗ |
Product code OVK · Class II · Immunology. Data: openFDA.