QTE · Class II · 21 CFR 866.6010

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
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Thymidine Kinase Activity Devices (Product Code QTE)

1 devices
1–1 of 1
Cleared Jul 29, 2022
DiviTum TKa
K202852
Biovica International AB
Immunology · 669d

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 remained relatively stable over the observed period, with 0 submissions in the last 24 months.