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

Name: FDA 510(k) clearance K203245
Creator: U.S. Food and Drug Administration
Published: 2023-05-04

Substantially Equivalent

Nucleix , Ltd.

FDA 510(k) clearance K203245 for Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C, Substantially Equivalent on 2023-05-04. Applicant: Nucleix , Ltd.. Device class: 2.

Clearance details

Applicant: Nucleix , Ltd.
Product code: Code MMW
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2020-11-03
Decision date: 2023-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehovot, IL

Download summary PDF View on FDA.gov ↗

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