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FDA 510(k) K203245 — Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C

FDA 510(k) index record K203245. Device: Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C. Applicant as listed: Nucleix , Ltd.. Decision date: 2023-05-04.

OtherU.S. Food and Drug Administration (FDA)2023-05-04

Fuente

"device_name": "Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C"

Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-29

Disclaimer

professional use

References

FDA 510(k) public index record K203245.

Device name: Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C. Applicant as listed: Nucleix , Ltd..

Decision date: 2023-05-04. Decision wording: Substantially Equivalent.

Product code: MMW. Regulation: 21 CFR 866.6010. Medical specialty: Immunology.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

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