Name: Predicase
Price: 199 USD

K-number	K203245
Device name	Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C
Applicant	Nucleix , Ltd.
Product code	MMW
Device class	Class II
Decision date	May 4, 2023
Decision	Substantially Equivalent
Regulation	866.6010

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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

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