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FDA 510(k)

CEDIA DAU AMPHASSURE ASSAY

K-Number: K994380 · 2000-05-02

ApplicantMicrogenics Corp.
Decision Date2000-05-02
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CEDIA DAU AMPHASSURE 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 2000-05-02 under 510(k) number K994380. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEDIA DAU AMPHASSURE ASSAY?

CEDIA DAU AMPHASSURE ASSAY is a medical device that received FDA 510(k) clearance on 2000-05-02. The listed applicant is Microgenics Corp.. The 510(k) number is K994380.

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

CEDIA DAU AMPHASSURE ASSAY received FDA 510(k) clearance on 2000-05-02, under 510(k) number K994380.

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

The FDA product code for CEDIA DAU AMPHASSURE ASSAY is DKZ.

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Other records listing Microgenics Corp. as applicant

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Related Devices (Code: DKZ)

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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