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FDA 510(k)

DRI OXYCODONE ASSAY

K-Number: K040411 · 2004-05-27

ApplicantMicrogenics Corp.
Decision Date2004-05-27
Product CodeLAS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRI OXYCODONE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 2004-05-27 under 510(k) number K040411. The device is classified under product code LAS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRI OXYCODONE ASSAY?

DRI OXYCODONE ASSAY is a medical device that received FDA 510(k) clearance on 2004-05-27. The listed applicant is Microgenics Corp.. The 510(k) number is K040411.

When did DRI OXYCODONE ASSAY receive FDA 510(k) clearance?

DRI OXYCODONE ASSAY received FDA 510(k) clearance on 2004-05-27, under 510(k) number K040411.

Who is the listed applicant for DRI OXYCODONE ASSAY?

The FDA 510(k) record lists Microgenics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRI OXYCODONE ASSAY?

The FDA product code for DRI OXYCODONE ASSAY is LAS.

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Other records listing Microgenics Corp. as applicant

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Related Devices (Code: LAS)

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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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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