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FDA 510(k)

CEDIA Heroin Metabolite (6-AM) Assay

K-Number: K173183 · 2017-11-22

ApplicantMicrogenics Corporation
Decision Date2017-11-22
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA Heroin Metabolite (6-AM) Assay is a medical device manufactured by Microgenics Corporation. It received FDA 510(k) clearance on 2017-11-22 under approval number K173183. 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 CEDIA Heroin Metabolite (6-AM) Assay?

CEDIA Heroin Metabolite (6-AM) Assay is a medical device that received FDA 510(k) clearance on 2017-11-22. It is manufactured by Microgenics Corporation. The 510(k) number is K173183.

When was CEDIA Heroin Metabolite (6-AM) Assay approved by the FDA?

CEDIA Heroin Metabolite (6-AM) Assay received FDA 510(k) clearance on 2017-11-22, under approval number K173183.

What company makes CEDIA Heroin Metabolite (6-AM) Assay?

CEDIA Heroin Metabolite (6-AM) Assay is manufactured by Microgenics Corporation.

What is the FDA product code for CEDIA Heroin Metabolite (6-AM) Assay?

The FDA product code for CEDIA Heroin Metabolite (6-AM) Assay is DJG.

Other Devices by Microgenics Corporation

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Related Devices (Code: 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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