K202852 is an FDA 510(k) clearance for the DiviTum TKa. This device is classified as a Thymidine Kinase Activity (Class II - Special Controls, product code QTE).
Submitted by Biovica International AB (Uppsala, SE). The FDA issued a Cleared decision on July 29, 2022, 669 days after receiving the submission on September 28, 2020.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010. In Vitro Test To Measure Thymidine Kinase Activity (tka) To Aid In Monitoring Disease Progression Of Breast Cancer Patients..
| 510(k) Number | K202852 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2020 |
| Decision Date | July 29, 2022 |
| Days to Decision | 669 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | QTE - Thymidine Kinase Activity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |
| Definition | In Vitro Test To Measure Thymidine Kinase Activity (tka) To Aid In Monitoring Disease Progression Of Breast Cancer Patients. |