510(k) K202852
K202852 is an FDA 510(k) premarket notification submitted by Biovica International AB for the device "DiviTum TKa". The FDA issued a decision of Substantially Equivalent on July 29, 2022. The device falls under product code QTE (Thymidine Kinase Activity), a Class II device regulated under 21 CFR 866.6010.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2022
- Date Received
- September 28, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thymidine Kinase Activity
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- IM
- Submission Type
In vitro test to measure thymidine kinase activity (TKa) to aid in monitoring disease progression of breast cancer patients.