Clearance Summary
DiviTum TKa received FDA 510(k) clearance under submission number K202852, sponsored by Biovica International AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2022-07-29.
- Submission: K202852
- Applicant / Sponsor: Biovica International AB
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2022-07-29
Classification & Regulation
This clearance is catalogued under FDA product code QTE and 21 CFR 866.6010, within the Immunology review panel as a Class II device.