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FDA 510(k)

DRI Ecstasy Plus Assay

K-Number: K240670 · 2024-10-30

ApplicantMicrogenics Corporation
Decision Date2024-10-30
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Microgenics Corporation. The 510(k) number is K240670.

When was DRI Ecstasy Plus Assay approved by the FDA?

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

What company makes DRI Ecstasy Plus Assay?

DRI Ecstasy Plus Assay is manufactured by Microgenics Corporation.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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