FDA 510(k)

MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup

Número K: K162395 · 2017-06-02

Data da decisão2017-06-02

Código do produtoDIO

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Mp Biomedicals, LLC. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K162395. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup?

MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Mp Biomedicals, LLC. The 510(k) number is K162395.

When did MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup receive FDA 510(k) clearance?

MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup received FDA 510(k) clearance on 2017-06-02, under 510(k) number K162395.

Who is the listed applicant for MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup?

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

What is the FDA product code for MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup?

The FDA product code for MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup is DIO.

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