DiviTum TKa
FDA 510(k) clearance K202852 · decided 2022-07-29
Clearance details
- K-number
- K202852
- Device name
- DiviTum TKa
- Applicant
- Biovica International AB
- Decision
- Substantially Equivalent
- Date received
- 2020-09-28
- Decision date
- 2022-07-29
- Days to decision
- 669 days
- Clearance type
- Traditional
- Product code
- QTE
- Device class
- 2
- Regulation number
- 866.6010
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Uppsala, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.