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FDA 510(k)

DRI Hydrocodone Assay

K-Number: K173195 · 2018-02-13

ApplicantMicrogenics Corporation
Decision Date2018-02-13
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRI Hydrocodone 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 2018-02-13 under 510(k) number K173195. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRI Hydrocodone Assay?

DRI Hydrocodone Assay is a medical device that received FDA 510(k) clearance on 2018-02-13. The listed applicant is Microgenics Corporation. The 510(k) number is K173195.

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

DRI Hydrocodone Assay received FDA 510(k) clearance on 2018-02-13, under 510(k) number K173195.

Who is the listed applicant for DRI Hydrocodone 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 Hydrocodone Assay?

The FDA product code for DRI Hydrocodone Assay is DJG.

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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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