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FDA 510(k)

DRI Cocaine Metabolite Assay

K-Number: K211973 · 2021-09-24

ApplicantMicrogenics Corporation
Decision Date2021-09-24
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRI Cocaine Metabolite Assay is a medical device manufactured by Microgenics Corporation. It received FDA 510(k) clearance on 2021-09-24 under approval number K211973. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRI Cocaine Metabolite Assay?

DRI Cocaine Metabolite Assay is a medical device that received FDA 510(k) clearance on 2021-09-24. It is manufactured by Microgenics Corporation. The 510(k) number is K211973.

When was DRI Cocaine Metabolite Assay approved by the FDA?

DRI Cocaine Metabolite Assay received FDA 510(k) clearance on 2021-09-24, under approval number K211973.

What company makes DRI Cocaine Metabolite Assay?

DRI Cocaine Metabolite Assay is manufactured by Microgenics Corporation.

What is the FDA product code for DRI Cocaine Metabolite Assay?

The FDA product code for DRI Cocaine Metabolite Assay is DIO.

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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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