K203245 is an FDA 510(k) clearance for the Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C. This device is classified as a System, Test, Tumor Marker, Monitoring, Bladder (Class II - Special Controls, product code MMW).
Submitted by Nucleix , Ltd. (Rehovot, IL). The FDA issued a Cleared decision on May 4, 2023, 912 days after receiving the submission on November 3, 2020.
This device falls under the Medical Genetics FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K203245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2020 |
| Decision Date | May 04, 2023 |
| Days to Decision | 912 days |
| Submission Type | Traditional |
| Review Panel | Medical Genetics (MG) |
| Summary | Summary PDF |
| Product Code | MMW - System, Test, Tumor Marker, Monitoring, Bladder |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |