Clearance Summary
Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C received FDA 510(k) clearance under submission number K203245, sponsored by Nucleix , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2023-05-04.
- Submission: K203245
- Applicant / Sponsor: Nucleix , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.6010
- Decision date: 2023-05-04
Classification & Regulation
This clearance is catalogued under FDA product code MMW and 21 CFR 866.6010, within the Immunology review panel as a Class II device.