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FDA 510(k)

CEDIA BUPRENORPHINE ASSAY

K-Number: K040316 · 2004-06-23

ApplicantMicrogenics Corp.
Decision Date2004-06-23
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA BUPRENORPHINE 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 2004-06-23 under 510(k) number K040316. 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 BUPRENORPHINE ASSAY?

CEDIA BUPRENORPHINE ASSAY is a medical device that received FDA 510(k) clearance on 2004-06-23. The listed applicant is Microgenics Corp.. The 510(k) number is K040316.

When did CEDIA BUPRENORPHINE ASSAY receive FDA 510(k) clearance?

CEDIA BUPRENORPHINE ASSAY received FDA 510(k) clearance on 2004-06-23, under 510(k) number K040316.

Who is the listed applicant for CEDIA BUPRENORPHINE 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 CEDIA BUPRENORPHINE ASSAY?

The FDA product code for CEDIA BUPRENORPHINE 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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