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FDA 510(k)

CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS

K-Number: K935904 · 1994-03-11

ApplicantMicrogenics Corp.
Decision Date1994-03-11
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS is the device name listed in this FDA 510(k) record. The listed applicant is Microgenics Corp.. It received FDA 510(k) clearance on 1994-03-11 under 510(k) number K935904. 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 HITACHI 717 AND 704 ANALYZERS?

CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS is a medical device that received FDA 510(k) clearance on 1994-03-11. The listed applicant is Microgenics Corp.. The 510(k) number is K935904.

When did CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS receive FDA 510(k) clearance?

CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS received FDA 510(k) clearance on 1994-03-11, under 510(k) number K935904.

Who is the listed applicant for CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS?

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 HITACHI 717 AND 704 ANALYZERS?

The FDA product code for CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS is DIO.

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Other records listing Microgenics Corp. as applicant

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Related Devices (Code: DIO)

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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