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FDA 510(k)

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

N.º K: K203245 · 2023-05-04

SolicitanteNucleix , Ltd.
Fecha de decisión2023-05-04
Código de productoMMW
Comité asesorIM
DecisiónSubstantially Equivalent

Resumen del dispositivo

Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C is the device name listed in this FDA 510(k) record. The listed applicant is Nucleix , Ltd.. It received FDA 510(k) clearance on 2023-05-04 under 510(k) number K203245. The device is classified under product code MMW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C?

Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C is a medical device that received FDA 510(k) clearance on 2023-05-04. The listed applicant is Nucleix , Ltd.. The 510(k) number is K203245.

When did Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C receive FDA 510(k) clearance?

Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C received FDA 510(k) clearance on 2023-05-04, under 510(k) number K203245.

Who is the listed applicant for Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C?

The FDA 510(k) record lists Nucleix , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C?

The FDA product code for Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C is MMW.

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Fuente oficial

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