Panels › Immunology › Product code OVK · Class 2
Cytokeratin Fragments 21-1 Eia Kit
Regulation 866.6010
1510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OVK
| Company | 510(k)s | Recalls |
|---|---|---|
| Fujirebio Diagnostics,Inc. | 2 | 0 |
| Roche Diagnostics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 16, 2025 | K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 Fujirebio Diagnostics,Inc. | OVK |
| Dec 14, 2016 | K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker Roche Diagnostics | OVK |
| May 26, 2011 | K100831 | CYFRA 21-1 EIA MODEL 211-10 Fujirebio Diagnostics,Inc. | OVK |
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