DiviTum TKa— 510(k) K202852
Substantially EquivalentBiovica International AB
FDA 510(k) clearance K202852 for DiviTum TKa, Substantially Equivalent on 2022-07-29. Applicant: Biovica International AB. Device class: 2.
Clearance details
- Applicant
- Biovica International AB
- Product code
- Code QTE
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Uppsala, SE
Data sourced from openFDA. This site is unofficial and independent of the FDA.