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FDA 510(k)

DRI METHADONE METABOLITE ENZYME IMMUNOASSAY

K-Number: K023617 · 2003-08-27

ApplicantMicrogenics Corp.
Decision Date2003-08-27
Product CodeDJR
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRI METHADONE METABOLITE ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 2003-08-27 under 510(k) number K023617. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRI METHADONE METABOLITE ENZYME IMMUNOASSAY?

DRI METHADONE METABOLITE ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2003-08-27. The listed applicant is Microgenics Corp.. The 510(k) number is K023617.

When did DRI METHADONE METABOLITE ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

DRI METHADONE METABOLITE ENZYME IMMUNOASSAY received FDA 510(k) clearance on 2003-08-27, under 510(k) number K023617.

Who is the listed applicant for DRI METHADONE METABOLITE ENZYME IMMUNOASSAY?

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 METHADONE METABOLITE ENZYME IMMUNOASSAY?

The FDA product code for DRI METHADONE METABOLITE ENZYME IMMUNOASSAY is DJR.

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Related Devices (Code: DJR)

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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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