ADVIA Centaur Cytokeratin Fragment 21-1
FDA 510(k) clearance K250925 · decided 2025-12-16
Clearance details
- K-number
- K250925
- Device name
- ADVIA Centaur Cytokeratin Fragment 21-1
- Applicant
- Fujirebio Diagnostics,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-27
- Decision date
- 2025-12-16
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- OVK
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Malvern, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (K160915) | Roche Diagnostics | 2016-12-14 |
| CYFRA 21-1 EIA MODEL 211-10 (K100831) | Fujirebio Diagnostics,Inc. | 2011-05-26 |
Recalls involving this device
No recalls on record reference this clearance.