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FDA 510(k)

CEDIA DAU 6-ACETYLMORPHINE ASSAY

K-Number: K001178 · 2000-06-09

ApplicantMicrogenics Corp.
Decision Date2000-06-09
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA DAU 6-ACETYLMORPHINE 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 2000-06-09 under 510(k) number K001178. 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 DAU 6-ACETYLMORPHINE ASSAY?

CEDIA DAU 6-ACETYLMORPHINE ASSAY is a medical device that received FDA 510(k) clearance on 2000-06-09. The listed applicant is Microgenics Corp.. The 510(k) number is K001178.

When did CEDIA DAU 6-ACETYLMORPHINE ASSAY receive FDA 510(k) clearance?

CEDIA DAU 6-ACETYLMORPHINE ASSAY received FDA 510(k) clearance on 2000-06-09, under 510(k) number K001178.

Who is the listed applicant for CEDIA DAU 6-ACETYLMORPHINE 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 DAU 6-ACETYLMORPHINE ASSAY?

The FDA product code for CEDIA DAU 6-ACETYLMORPHINE ASSAY is DJG.

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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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