510(k) K202852
- Device
- DiviTum TKa
- Applicant
- Biovica International AB
- 510(k) number
- K202852
- Product code
- OVK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-07-29
- Date received
- 2020-09-28
- Regulation
- 866.6010
- Classification name
- Cytokeratin Fragments 21-1 Eia Kit
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Joakim Arwidson
- Address
- Dag Hammarskjölds Väg 54b Uppsala SE 75237 75237
FDA Registration Numbers#
- 3008629194
Source Documents#
Other 510(k) Records For Product Code OVK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | 2025-12-16 |
| K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | Roche Diagnostics | 2016-12-14 |
| K100831 | CYFRA 21-1 EIA MODEL 211-10 | Fujirebio Diagnostics,Inc. | 2011-05-26 |
Legacy Summary#
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FDA Review#
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