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

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..

Clearance details

Applicant
Nucleix , Ltd.
Product code
Code MMW
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rehovot, IL
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