Cleared Traditional

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

K203245 · Nucleix , Ltd. · Medical Genetics

May 2023

Decision

912d

Days

Class 2

Risk

About This 510(k) Submission

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, 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 review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K203245 FDA.gov
FDA Decision	Cleared 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