FDA 510(k)

DRI Ecstasy Plus Assay

Número K: K240670 · 2024-10-30

Data da decisão2024-10-30

Código do produtoDKZ

Comité consultivoTX

DecisãoSubstantially Equivalent

Resumo do dispositivo

DRI Ecstasy Plus Assay is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corporation. It received FDA 510(k) clearance on 2024-10-30 under 510(k) number K240670. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DRI Ecstasy Plus Assay?

DRI Ecstasy Plus Assay is a medical device that received FDA 510(k) clearance on 2024-10-30. The listed applicant is Microgenics Corporation. The 510(k) number is K240670.

When did DRI Ecstasy Plus Assay receive FDA 510(k) clearance?

DRI Ecstasy Plus Assay received FDA 510(k) clearance on 2024-10-30, under 510(k) number K240670.

Who is the listed applicant for DRI Ecstasy Plus Assay?

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

What is the FDA product code for DRI Ecstasy Plus Assay?

The FDA product code for DRI Ecstasy Plus Assay is DKZ.

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