CYFRA 21-1 EIA MODEL 211-10
FDA 510(k) clearance K100831 · decided 2011-05-26
Clearance details
- K-number
- K100831
- Device name
- CYFRA 21-1 EIA MODEL 211-10
- Applicant
- Fujirebio Diagnostics,Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-24
- Decision date
- 2011-05-26
- Days to decision
- 428 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 |
|---|---|---|
| ADVIA Centaur Cytokeratin Fragment 21-1 (K250925) | Fujirebio Diagnostics,Inc. | 2025-12-16 |
| Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (K160915) | Roche Diagnostics | 2016-12-14 |
Recalls involving this device
No recalls on record reference this clearance.