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FDA 510(k)

CEDIA Heroin Metabolite (6-AM) assay

K-Number: K192943 · 2019-12-16

ApplicantMicrogenics Corporation
Decision Date2019-12-16
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA Heroin Metabolite (6-AM) 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 2019-12-16 under 510(k) number K192943. 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 2019-12-16. The listed applicant is Microgenics Corporation. The 510(k) number is K192943.

When did CEDIA Heroin Metabolite (6-AM) assay receive FDA 510(k) clearance?

CEDIA Heroin Metabolite (6-AM) assay received FDA 510(k) clearance on 2019-12-16, under 510(k) number K192943.

Who is the listed applicant for CEDIA Heroin Metabolite (6-AM) 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 CEDIA Heroin Metabolite (6-AM) assay?

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

Other records listing Microgenics Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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