FDA Product Code QTE: Thymidine Kinase Activity
In Vitro Test To Measure Thymidine Kinase Activity (tka) To Aid In Monitoring Disease Progression Of Breast Cancer Patients.
Leading manufacturers include Biovica International AB.
1
Total
1
Cleared
669d
Avg days
2022
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Thymidine Kinase Activity Devices (Product Code QTE)
1 devices
About Product Code QTE - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QTE since 2022, with 1 receiving FDA clearance (average review time: 669 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QTE devices are reviewed by the Immunology panel. Browse all Immunology devices →