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FDA 510(k)

CEDIA DAU COCAINE ASSAY

K-Number: K945345 · 1995-01-17

ApplicantMicrogenics Corp.
Decision Date1995-01-17
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA DAU COCAINE 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 1995-01-17 under 510(k) number K945345. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEDIA DAU COCAINE ASSAY?

CEDIA DAU COCAINE ASSAY is a medical device that received FDA 510(k) clearance on 1995-01-17. The listed applicant is Microgenics Corp.. The 510(k) number is K945345.

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

CEDIA DAU COCAINE ASSAY received FDA 510(k) clearance on 1995-01-17, under 510(k) number K945345.

Who is the listed applicant for CEDIA DAU COCAINE 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 COCAINE ASSAY?

The FDA product code for CEDIA DAU COCAINE ASSAY is DIO.

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Related Devices (Code: DIO)

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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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