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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 the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corporation. It received FDA 510(k) clearance on 2021-09-24 under 510(k) 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. The listed applicant is Microgenics Corporation. The 510(k) number is K211973.

When did DRI Cocaine Metabolite Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for DRI Cocaine Metabolite 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 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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